Product code JPA— Hematology
Sysmex Automated Blood Coagulation Analyzer CS-5100
- Classification name
- System, Multipurpose For In Vitro Coagulation Studies
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Total cleared
- 181
- First cleared
- Most recent
Clearances under product code JPA — page 2
101–181 of 181- K930849 — VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA
- K925340 — COAGULATION CONTROL CONTAINING HEMOGLOBIN
- K926222 — OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
- K923761 — ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM
- K924509 — CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION
- K924453 — MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)
- K924124 — BEHRING FIBRINTIMER A
- K924393 — STANDARD HUMAN PLASMA
- K914188 — KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM
- K912087 — ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS
- K912061 — HEPARIN ADSORBENT
- K902458 — ACS 0.02 M CALCIUM CHLORIDE
- K900917 — COAG-A-MATE - RA4
- K900506 — MODIFIED COATRON II AND COATRON JR.
- K900377 — COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN
- K894359 — CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS
- K894466 — HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS
- K893650 — PLATELET AGGREGATION PROFILER MODEL PAP-4C
- K884534 — PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER
- K885076 — COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE
- K883689 — ORTHO OWREN'S BUFFER
- K883635 — KD 0.1 M SODIUM CITRATE SOLUTION
- K883637 — KD 0.02 M CALCIUM CHLORIDE SOLUTION
- K883640 — KD ONE-STAGE PROTHROMBIN TIME TEST
- K882444 — COAG-I ANALYZER, ALPHA MODEL
- K883484 — OWREN'S VERONAL BUFFER
- K881367 — ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS
- K880713 — CLP 0.1 M SODIUM CITRATE SOLUTION
- K875089 — HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN
- K872377 — CHROM-TROL
- K870831 — PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA
- K870771 — PT HEPARIN ADSORBENT
- K870685 — COAGULATION CONTROL, LEVEL I
- K870686 — COAGULATION CONTROL, LEVEL II
- K870687 — COAGULATION CONTROL, LEVEL III
- K870688 — O.O2 M CALCIUM CHLORIDE SOLUTION
- K870960 — COAG-A-MATE(R) XC
- K864532 — ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER
- K864534 — ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER
- K864271 — IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA
- K862537 — KOAGULAB* M COAGULATION SYSTEM
- K860719 — BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)
- K854938 — COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.
- K860342 — MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP
- K854546 — MICROSAMPLE COAGULATION ANALYSER MODEL 110P
- K854089 — DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT
- K854090 — DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT
- K854376 — HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS
- K853986 — THROMBOPLASTIN-R REAGENT
- K851153 — COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE
- K853328 — KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS
- K853198 — ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES
- K853789 — ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR
- K852450 — LODE COAGULOMETER MODEL LC-6
- K853246 — CALCIUM CHLORIDE
- K853076 — CITREX I
- K853077 — CITREX II
- K853078 — CITREX III
- K851127 — DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO
- K850409 — GEN. DIAG. CHROMOSTRATE REF. PLASMA
- K842717 — COBAS-FIBRO
- K841462 — HEPARIN COAGULATION CONTROL PLASMA 1-
- K841523 — OWREN'S VERONAL BUFFERR
- K833272 — THROMBOPLASTIN - FS
- K832225 — ORTHO ABNORMAL COAGULATION LEVEL I/II
- K812121 — DIGICLOT 2-#820
- K812122 — MULTI CLOT-#819
- K812124 — MLA ELECTRA 700
- K792310 — NORM-TROL
- K791586 — ELVI 818 DIGICLOT MULTISCAN
- K790323 — COAG-A-MATE 2001
- K790204 — PLASMA, STANDARDIZED NORMAL
- K780810 — MLA ELECTRA 750 COAGULATION TIMER
- K770606 — ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH
- K761091 — TPC-LYOPHILIZED POOLED HUMAN PLASMA
- K761171 — VERONAL BUFFER
- K761172 — TRIS BUFFERED SALINE
- K761173 — TRIS BUFFERED
- K761175 — IMIDAZOLE BUFFER (0.05M)
- K761176 — CALCIUM CHLORIDE (0.025M)
- K760594 — AUTO-FI COAGULATION INSTRUMENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.