Product code CIT— Clinical Chemistry
AST
- Classification name
- Nadh Oxidation/Nad Reduction, Ast/Sgot
- Device class
- Class 2
- Regulation
- 21 CFR 862.1100
- Advisory panel
- Clinical Chemistry
- Total cleared
- 139
- First cleared
- Most recent
Market context for product code CIT
FDA has cleared devices under product code CIT between 1976 and 2010, filed by 81 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2010
- 2008
- 2007
- 2006
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
Top applicants under product code CIT
Recent clearances under product code CIT
1–100 of 139- K093883 — AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-
- K080485 — ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
- K071525 — ACTIVATED ASPARTATE AMINOTRANSFERASE
- K071580 — AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
- K071211 — COBAS C 111 ANALYZER
- K060318 — HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
- K023551 — WIENER LAB GOT (AST) UV AA LIQUIDA
- K013698 — AST (SGOT)
- K013145 — WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.
- K010488 — ATAC PAK AST REAGENT KIT
- K001679 — VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
- K993468 — WAKO L-TYPE GOT TEST
- K992136 — BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
- K992801 — SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5
- K991663 — AST/SGOT
- K990009 — CARESIDE AST
- K983131 — AST
- K981650 — AST/SGOT LIQUID REAGENT - KINETIC METHOD
- K981843 — AST
- K981221 — ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
- K981225 — ASPARTATE AMINOTRANSFERASE (AST)
- K980902 — N-ASSAY L AST/GOT
- K980666 — INFINITY AST REAGENT (PROCEDURE NO. 51)
- K980030 — AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
- K974001 — ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30
- K971344 — AST OR SGOT
- K965126 — AST/SGOT
- K961114 — AST INCORPORATING DST
- K954992 — ROCHE COBAS INTEGRA REAGENT CASSETTES
- K954839 — ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV
- K952743 — ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM
- K951751 — HICHEM AST REAGENT KIT
- K944102 — AST QVET
- K941132 — LIQUID AST (SGOT)REAGENT SET
- K934413 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE
- K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST
- K932049 — STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020
- K925155 — OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT
- K924244 — ROCHE REAGENT FOR AST
- K923505 — AST (GOT) - ASPARTATE AMINOTRANSFERASE
- K923641 — IL TEST AST, PN 35312
- K922857 — SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO
- K922885 — OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT
- K922108 — KING DIAGNOSTICS AST (GOT) REAGENT
- K920336 — MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD
- K915555 — SYNERMED AST/GOT REAGENT KIT
- K914463 — ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42
- K914025 — TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)
- K914068 — ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST
- K905771 — COULTER DART AST (GOT) REAGENT
- K903829 — AST REAGENT
- K903197 — ASPARTATE AMINOTRANSFERASE TEST
- K901104 — PARAMAX ASPARTATE AMINOTRANSFERASE REAGENT
- K897165 — COULTER AST (GOT) REAGENT
- K896228 — COBAS READY CARDIO PROFILE REAGENT STRIP
- K896229 — COBAS READY PROFILE 1 REAGENT STRIP
- K896233 — COBAS READY LIVER PROFILE REAGENT STRIP
- K896000 — ASPARTATE AMINOTRANFERASE (AST)
- K894180 — ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54)
- K893692 — EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405
- K892844 — AST REAGENT (PROCEDURE NUMBER 158)
- K891468 — AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
- K884724 — ASPARTATE AMINOTRANSFERASE (AST)
- K885156 — CLINISTAT SGOT (AST) REAGENT TEST
- K884377 — ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654
- K880692 — ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC)
- K880276 — AST (SGOT) REAGENT SET
- K875071 — ASPARTATE AMINOTRANSFERASE AST/SGOT
- K874600 — EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010
- K872829 — BIOTROL AST/TGO MONOREACTIF
- K871780 — ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT)
- K870077 — ASPARTATE AMINOTRANSFERASE (AST)/(GOT)
- K870246 — REFLOTRON(R) AST (GOT)
- K864813 — WAKO (TM) AUTOKIT GOT TEST
- K864357 — AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
- K863054 — AST S.C.E. (GOT)
- K864302 — WAKO(TM) GOT II - HA
- K863963 — EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95
- K863257 — AST/GOT PROCEDURE
- K863094 — SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)
- K862832 — MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT
- K861656 — AST/GOT PROCEDURE
- K860465 — VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM
- K861283 — AST REAGENT CARTRIDGE
- K860725 — AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
- K860667 — ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET
- K854982 — VISION SGOT (AST)
- K854503 — AST(OPTIMIZED) REAGENT
- K852783 — SGOT/ALT REAGENT
- K851994 — AST ASPARTATE AMINOTRANSFERASE REAGENT
- K851865 — AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE
- K851267 — GEMENI AST-LTS REAGENTS
- K843109 — ROCHE REAGENT FOR AST
- K843333 — SYSTEMATE GOT 67208
- K842411 — SIGMA 58-UV ASPARTATE AMINOTRANSFERAS
- K842521 — AST/GOT REAGENT SET UV RATE
- K842245 — ASPARTATE AMINOTRANSFERASE ASSAY KIT
- K841066 — SGOT-UV REAGENT SET
- K840706 — ASPARTATE AMINOTRANSFERASE REAGENT
- K830958 — FLOW-PAC SGOT REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.