Product code CGS— Clinical Chemistry
CK-NAC REAGENT
- Classification name
- Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Total cleared
- 123
- First cleared
- Most recent
Market context for product code CGS
FDA has cleared devices under product code CGS between 1977 and 2020, filed by 72 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- 2020
- 2019
- 2016
- 2013
- 2011
- 2009
- 2008
- 2007
- 2006
- 2004
- 2002
- 2001
- 2000
- 1999
- 1998
Top applicants under product code CGS
Recent clearances under product code CGS
1–100 of 123- K191296 — Pointe Scientific Creatinine Kinase (CK) Reagent Set
- K182702 — SEKURE Creatine Kinase Assay
- K160724 — ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
- K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
- K112416 — CPK REAGENT
- K083465 — DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
- K081731 — DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32
- K072548 — CREATINE KINASE LIQUID REAGENT, MODEL C519-440
- K062737 — CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
- K051648 — SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS
- K043202 — OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
- K021332 — WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA
- K013912 — CREATINE KINASE (CK-NAC)
- K012474 — ATAC PAK CPK REAGENT KIT
- K994189 — OLYMPUS CREATINE KINASE REAGENT OSR6179/6279
- K992148 — HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT
- K983070 — CK
- K981218 — CREATINE KINASE (CK)
- K980900 — N-ASSAY CPK-L
- K973999 — CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30
- K974833 — CK-NAC REAGENT
- K972155 — CREATINE KINASE (CK)
- K971566 — CREATINE KINASE-MB REAGENT SET
- K971396 — CK REAGENT
- K962247 — HICHEM CK/NAC REAGENT KIT
- K951223 — CK-MB (NAC-ACT)
- K952745 — CREATINE KINASE REAGENT SYSTEM
- K952646 — IL TEST CK-MB
- K950177 — CK QVET
- K942773 — CK-MB ASSAY, CATALOGUE NUMBER 317-10
- K935463 — CREATINE KINASE-MB (CK-MB) REAGENT SET
- K933675 — OPUS TOTAL CK
- K931889 — CREATINE KINASE TEST
- K931326 — KING DIAGNOSTICS CK REAGENT
- K930932 — SYNERMED CREATINE KINASE REAGENT KIT
- K930660 — CREATINE KINASE (CK) REAGENT SET
- K924832 — OLYMPUS CREATINE KINASE REAGENT
- K925801 — REP E-Z CK-30 ISOENZYME KIT
- K923511 — CK-NAC ACTIVATED KIT
- K924704 — CREATINE KINASE (CK) TEST ITEM #65411
- K922459 — OLYMPUS CREATINE KINASE REAGENT
- K915709 — CREATINE KINASE-MB (CK-MB) REAGENT SET
- K914361 — CREATINE KINASE MB TEST ITEM NUMBER 5A46
- K913398 — RAICHEM(TM) CREATINE KINASE-MB REAGENT
- K905084 — RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV
- K904004 — AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116
- K903775 — CREATINE PHOSPHOKINASE
- K904102 — REFLOTRON CREATINE KINASE TEST TABS
- K903333 — CREATINE KINASE TEST (CK) ITEM NUMBER 65411
- K902483 — CREATINE KINASE-MB TEST (MB-DS) ITEM #67655
- K901267 — COULTER CK (CREATINE KINASE) REAGENT
- K894715 — CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS
- K893691 — EMDS CREATINE KINASE ITEM NIMBER 65411
- K893007 — REP(TM) CK-2 STAT KIT, CAT. NO. 3074
- K893269 — BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME
- K891462 — ROCHE(R) CARDIOSCREEN-CK
- K891470 — CK-NAC 2-VIAL REAGENT W/SUBSTRATE START
- K890609 — IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)
- K890540 — ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC
- K884547 — CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673
- K884546 — CREATINE KINASE TEST (CK) ITEM NUMBER: 65661
- K883946 — VISION CREATINE KINASE
- K883504 — DURAZYME(R) CPK
- K873201 — WAKO(TM) AUTOKIT CK-NAC
- K874146 — TITAN GEL REP CPK-12 HV
- K874139 — TITAN GEL REP CPK-30 HV
- K874140 — TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED.
- K873134 — UNIFAST CK-MB
- K870462 — EASY-TEST CREATINE KINASE-MB (CK-MB) #16615
- K870461 — EASY-TEST CREATINE KINASE (CK) NUMBER: 16614
- K864359 — CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)
- K864744 — CREATINE PHOSPHOKINASE (CK)
- K863587 — CREATINE PHOSPHOKINASE(CK) PROCEDURE
- K861665 — CREATINE PHROSPHOKINASE (CK) PROCEDURE
- K861879 — CK REAGENT CARTRIDGE (PRODUCT NO. 88213)
- K860733 — CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE
- K861061 — EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK
- K860669 — CREATINE KINASE, N-ACETYL-L-CYSTIENE
- K860096 — CPK REAGENT SET (COLORIMETRIC)
- K855056 — EMDS TOTAL CK TEST PACK-#67670/95
- K854501 — CK(OPTIMIZED) REAGENT
- K852392 — EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE
- K852483 — SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205
- K852000 — CK-NAC REAGENT
- K850212 — ISOENZYME TEST CK-MB
- K842755 — TITAN GEL ISO DOT CPK PROCEDURE
- K843271 — SYSTEMATE CK-TOTAL - 67206
- K842508 — CREATINE KINASE ASSAY KIT NAC
- K842013 — SIGMA PROCEDURE 47-UV
- K840783 — CREATINE KINASE MB REAGENT
- K834502 — CK-NAC REAGENT
- K833781 — DURAZYME CPK
- K831965 — CREATINE KINASE REAGENT CK LTS
- K831537 — PARAMAX CREATINE KINASE REAGENT
- K821883 — ULTRAZYME PLUS CK-I
- K821473 — ULTRAZYME PLUS CKI, #64978,65027&65028
- K821464 — CARDIOZYME PLUS CK-MB, #65045
- K821460 — ULTRAZYME PLUS CK-I, #64978,65027&65028
- K821240 — LIQUID-STAT LIQUID ENZYME REAGENT
- K820880 — SERALYZER CK REAGENT STRIPS
Data sourced from openFDA. This site is unofficial and independent of the FDA.