meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
53
Latest Decision
1998-06-12

Clearances · page 40 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K981864 ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 Beckman Coulter, Inc. JJX Class I 1998-06-12
K981580 HDL Abbott Laboratories LBS Class I 1998-06-11
K981377 ACE T4 REAGENT T4 CALIBRATORS Schiapparelli Biosystems, Inc. KLI Class II 1998-06-10
K981375 ACE T UPTAKE REAGENT TU CALIBRATORS Schiapparelli Biosystems, Inc. KHQ Class II 1998-06-10
K980047 URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER Yeongdong Pharmaceutical Corp. KQO Class I 1998-06-10
K981495 IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) Diagnostic Products Corp. JHS Class II 1998-06-10
K981743 OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc. CKB Class II 1998-06-09
K981840 CO2 Abbott Laboratories KHS Class II 1998-06-08
K981581 IRON Abbott Laboratories CFM Class I 1998-06-08
K981622 DADE TRU-LIQUID CARDIAC CONTROL Dade Behring, Inc. JJX Class I 1998-06-08
K981216 AMY Abbott Laboratories JFJ Class II 1998-06-08
K980996 COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) Roche Diagnostic Systems, Inc. KHS Class II 1998-06-05
K981770 RAPIDHCG PREGNANCY TEST Rapid Diagnostics, Inc. JHI Class II 1998-06-05
K981312 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM Bayer Corp. JLW Class II 1998-06-05
K981609 BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 Diagnostic Chemicals , Ltd. CIG Class II 1998-06-03
K981722 QUIDEL HOME PREGNANCY TEST Quidel Corp. LCX Class II 1998-06-03
K981240 CREATININE (CREA) Abbott Laboratories CGX Class II 1998-05-29
K981512 ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025 Skd, Inc. A Beckman Coulter Co. JHI Class II 1998-05-28
K981457 ALBP Abbott Mfg., Inc. CJW Class II 1998-05-27
K981373 ALKPHASE-B ASSAY KIT Metra Biosystems, Inc. CIN Class II 1998-05-27
K981468 ALBG Abbott Laboratories CIX Class II 1998-05-27
K981607 ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 Diagnostic Systems Laboratories, Inc. CIB Class II 1998-05-27
K981099 STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK Dade Behring, Inc. JHX Class II 1998-05-26
K980731 ACCU-CHEK COMFORT CURVE TEST STRIPS Boehringer Mannheim Corp. LFR Class II 1998-05-22
K974695 COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) Roche Diagnostic Systems, Inc. CKB Class II 1998-05-21
K981245 ALKALINE PHOSPHATASE (ALKP) Abbott Laboratories CJE Class II 1998-05-20
K981279 TIBC Abbott Laboratories JMO Class I 1998-05-20
K981401 BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS Boehringer Mannheim Corp. JJY Class I 1998-05-18
K981338 LD-1 Abbott Laboratories JGF Class II 1998-05-18
K981232 CA Abbott Mfg., Inc. CJY Class II 1998-05-18
K981455 THIRD GENERATION PSA CONTROL MODULE Diagnostic Products Corp. JJY Class I 1998-05-13
K981231 CO2 Abbott Mfg., Inc. KHS Class II 1998-05-12
K981532 LYPHOCHEK IMMUNOASSAY PLUS CONTROL Bio-Rad JJY Class I 1998-05-12
K981183 CARESIDE GLUCOSE Exigent Diagnostics, Inc. CGA Class II 1998-05-07
K981474 CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) Spectral Diagnostics, Inc. JJY Class I 1998-05-07
K981189 URIC ACID Abbott Laboratories CDO Class I 1998-05-07
K981185 GLU Abbott Laboratories CFR Class II 1998-05-07
K981305 OLYMPUS SERUM PROTEIN MULTICALIBRATOR Olympus America, Inc. JIX Class II 1998-05-07
K980646 IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES Instrumentation Laboratory CO MQM Class I 1998-05-06
K981276 N-ASSAY L D-BIL Crestat Diagnostics, Inc. CIG Class II 1998-05-01
K981270 IRMA BLOOD ANALYSIS SYSTEM Diametrics Medical, Inc. CGZ Class II 1998-05-01
K981241 IRON Abbott Laboratories JIY Class I 1998-05-01
K980650 REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL Helena Laboratories JHO Class I 1998-05-01
K981192 MG Abbott Laboratories JGJ Class I 1998-05-01
K980833 IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 Diagnostic Products Corp. JMM Class I 1998-05-01
K981218 CREATINE KINASE (CK) Abbott Laboratories CGS Class II 1998-05-01
K981336 TBIL Abbott Laboratories CIG Class II 1998-05-01
K973335 QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) Zenyx Scientific , Ltd. JQW Class I 1998-04-30
K981060 ABBOTT AXSYM 3RD GENERATION TSH ASSAY Abbott Laboratories JLW Class II 1998-04-29
K980772 HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 Diagnostic Chemicals , Ltd. LBR Class I 1998-04-27
K981098 STRATUS CS CARDIAC TROPONIN I TESTPAK Dade Behring, Inc. MMI Class II 1998-04-27
K981289 N-ASSAY L T-BIL Crestat Diagnostics, Inc. CIG Class II 1998-04-27
K981436 DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 Casco Standards JIX Class II 1998-04-24
K981123 UREA Trace Scientific , Ltd. CDQ Class II 1998-04-24
K981281 ELECSYS CALCHECK FERRITIN Roche Diagnostics GmbH JJX Class I 1998-04-24
K981222 DIRECT BILIRUBIN (DBIL) Abbott Laboratories CIG Class II 1998-04-24
K981225 ASPARTATE AMINOTRANSFERASE (AST) Abbott Laboratories CIT Class II 1998-04-23
K981221 ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) Abbott Laboratories CIT Class II 1998-04-23
K981278 ELECSYS CALCHECK CA 125II Roche Diagnostics GmbH JJX Class I 1998-04-23
K981035 PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES Sims Portex, Inc. JKA Class II 1998-04-21
K980757 ILAB 600 CLINICAL CHEMISTRY SYSTEM Instrumentation Laboratory CO CGZ Class II 1998-04-21
K981339 QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 Consolidated Technologies, Inc. JJY Class I 1998-04-21
K980770 HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 Diagnostic Chemicals , Ltd. LBR Class I 1998-04-21
K980667 INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) Sigma Diagnostics, Inc. CHH Class I 1998-04-21
K981106 UREA NITROGEN (BUN) LIQUID REAGENT Teco Diagnostics CDQ Class II 1998-04-16
K981097 STRATUS CS CKMB CALPAK Dade Behring, Inc. JIT Class II 1998-04-16
K981100 STRATUS CS TROP CALPAK Dade Behring, Inc. JIT Class II 1998-04-16
K981165 AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST Germaine Laboratories, Inc. JHI Class II 1998-04-16
K980736 ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST Acon Laboratories Co. JHI Class II 1998-04-16
K971157 MACRALP(A) ENZYME IMMUNOASSAY KIT Strategic Diagnostics, Inc. JHO Class I 1998-04-15
K980991 NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER Nova Biomedical Corp. CHL Class II 1998-04-15
K981101 STRATUS CS MYO CALPAK Dade Behring, Inc. JIT Class II 1998-04-15
K980525 UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD Marukin Shoyu Co., Ltd. KWX Class II 1998-04-15
K974059 ONE STEP MIDSTREAM HCG PREGNANCY TEST International Newtech Development, Inc. LCX Class II 1998-04-09
K974060 MINISTRIP/ SERUM AND URINE COMBO HCG TEST International Newtech Development, Inc. JHI Class II 1998-04-09
K980819 BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS Biocircuits Corp. CEC Class II 1998-04-03
K980896 QUICKCARD PRO HCG TEST, MODEL 9008 Phamatech JHI Class II 1998-04-02
K980367 AEROSET SYSTEM Abbott Laboratories CGZ Class II 1998-04-01
K980043 CARESIDE CREATININE Exigent Diagnostics, Inc. JFY Class II 1998-03-30
K980900 N-ASSAY CPK-L Crestat Diagnostics, Inc. CGS Class II 1998-03-26
K980902 N-ASSAY L AST/GOT Crestat Diagnostics, Inc. CIT Class II 1998-03-26
K980574 AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0 Alfa Biotech (Uk) , Ltd. JLW Class II 1998-03-24
K980666 INFINITY AST REAGENT (PROCEDURE NO. 51) Sigma Diagnostics, Inc. CIT Class II 1998-03-20
K970093 TYROSINE 50-HOUR REAGENT KIT Astoria-Pacific, Inc. CDR Class I 1998-03-19
K980523 IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE Diametrics Medical, Inc. CHL Class II 1998-03-19
K980173 ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 Beckman Instruments, Inc. JHI Class II 1998-03-18
K973628 VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA Vital Scientific N.V. JJF Class I 1998-03-13
K974009 PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG International Newtech Development, Inc. JHI Class II 1998-03-13
K973999 CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 Diagnostic Chemicals , Ltd. CGS Class II 1998-03-11
K980532 QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012 Phamatech LCX Class II 1998-03-11
K980026 GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) Trace America, Inc. CFR Class II 1998-03-10
K980518 OSTEOMARK Ostex Intl., Inc. JMM Class I 1998-03-06
K980531 AIMSTEP PREGNANCY Germaine Laboratories, Inc. JHI Class II 1998-03-06
K973993 RANDOX CREATININE Randox Laboratories, Ltd. CGX Class II 1998-03-06
K980056 CARESIDE ANALYZER Exigent Diagnostics, Inc. JJF Class I 1998-03-06
K980514 CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002 Medical Analysis Systems, Inc. JJY Class I 1998-03-04
K980528 CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) Chiron Diagnostics Corp. MMI Class II 1998-03-03
K974721 UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. CGI Class I 1998-03-03
K980414 VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET Bd Becton Dickinson Vacutainer Systems Preanalytic JKA Class II 1998-03-03
K973108 TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 Diagnostic Chemicals , Ltd. CEK Class II 1998-03-02

13,065 clearances in the Clinical Chemistry panel. Data: openFDA.