meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
52
Latest Decision
1993-12-10

Clearances · page 56 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K934760 IMMUNLITE INTACT PTH Diagnostic Products Corp. CEW Class II 1993-12-10
K932766 HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) Diagnostic Chemicals, Ltd. (Usa) LBR Class I 1993-12-10
K934641 I-STAT CONTROL LEVELS 1,2,3 I-Stat Corp. JJR Class I 1993-12-09
K934961 SPINPRO HDL PRECIPITATING REAGENT Merchant House Scientific LBR Class I 1993-12-09
K935183 EMDS MAGNESIUM (MG) TEST Em Diagnostic Systems, Inc. JGJ Class I 1993-12-09
K935182 EMDS ALKANINE PHOSPHATASE (ALP) TEST Em Diagnostic Systems, Inc. CJE Class II 1993-12-09
K933692 SIGMA CO2 ACID REAGENT Sigma Chemical Co. JFL Class II 1993-12-09
K932623 QUANTIMETRIX BLOOD GLUCOSE CONTROLS Quantimetrix Corp. JIX Class II 1993-12-09
K934898 GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION Heraeus Kulzer, Inc. CGA Class II 1993-12-07
K934801 SPINPRO HDL PRECIPITATING REAGENT Merchant House Scientific LBR Class I 1993-12-07
K934900 GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION Heraeus Kulzer, Inc. CFR Class II 1993-12-07
K931196 APEC GLUCOSE ANALYZER Apec, Inc. CGA Class II 1993-12-07
K932715 CIBA CORNING ACS ESTRADIOL IMMUNOASSAY Ciba Corning Diagnostics Corp. CHP Class I 1993-12-03
K930776 COBAS CORE TSH EIA Roche Diagnostic Systems, Inc. JLW Class II 1993-12-03
K932608 COBAS(R) CORE T3 EIA Roche Diagnostic Systems, Inc. CDP Class II 1993-12-03
K932747 CIBA CORNING ACS FREE T3 IMMUNOASSAY Ciba Corning Diagnostics Corp. CDP Class II 1993-12-03
K934701 REAGENTS FOR COBAS ISE MODULE Alko Diagnostic Corp. JIX Class II 1993-12-02
K932406 NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT Nuclear Diagnostics, Inc. JNO Class I 1993-12-02
K932479 B-HCG HUMAN SERUM CONTROLS Pyramid Biological Corp. JJX Class I 1993-12-02
K934830 HCG PREGNANCY ONE STEP TEST STRIP Tcpi, Inc. LCX Class II 1993-12-02
K932366 UROPAPER EIKEN HAG Tanabe U.S.A., Inc. JIL Class II 1993-11-26
K934521 SPQ MALB CONTROL LEVEL II Incstar Corp. JJX Class I 1993-11-26
K934257 U-TROL LIQUID URINE DIPSTICK CONTROL P.T. Meditrol JJW Class I 1993-11-26
K932365 UROPAPER EIKEN AG Tanabe U.S.A., Inc. JIL Class II 1993-11-26
K934533 BUN-300/BUN-500 UREA NITROGEN REAGENT Horizon Diagnostics, Inc. CDQ Class II 1993-11-26
K932179 MODEL 400/450 ELECTROLYTE ANALYZER Ionetics, Inc. JGS Class II 1993-11-17
K932778 BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER Boehringer Mannheim Corp. JJQ Class I 1993-11-17
K926220 T3 UPTAKE CHEMILUMINESCENCE ASSAY Nichols Institute Diagnostics KHQ Class II 1993-11-17
K932369 UROPAPER EIKEN 7 Tanabe U.S.A., Inc. JIL Class II 1993-11-16
K931897 UROPAPER Tanabe U.S.A., Inc. JIL Class II 1993-11-16
K932049 STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 Stanbio Laboratory CIT Class II 1993-11-16
K932367 UROPAPER EIKEN 8 Tanabe U.S.A., Inc. JIL Class II 1993-11-16
K932364 UROPAPER EIKEN GP Tanabe U.S.A., Inc. JIL Class II 1993-11-16
K925093 SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA Beckman Instruments, Inc. JJF Class I 1993-11-16
K932363 UROPAPER EIKEN GK Tanabe U.S.A., Inc. JIL Class II 1993-11-16
K934361 OLYMPUS CREATININE REAGENT Olympus Corp. CGX Class II 1993-11-16
K934012 FT4 RADIOIMMUNOASSAY Immunotech S.A. CEC Class II 1993-11-16
K934039 INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET Intersect Systems, Inc. LBR Class I 1993-11-16
K930322 FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) Heraeus Kulzer, Inc. CEC Class II 1993-11-10
K926362 GLUCOSTIX REAGENT STRIPS Heraeus Kulzer, Inc. CGA Class II 1993-11-10
K930689 AUTOBEAD THYROID UPTAKE Bio-Chem Laboratory Systems, Inc. KHO Class I 1993-11-10
K932517 IRON/UIBC REAGENT Sigma Diagnostics, Inc. JMO Class I 1993-11-09
K932084 AIA-PACK E2 ASSAY Tosoh Medics, Inc. CHP Class I 1993-11-09
K934271 BECKMAN SYNCHRON LACTATE REAGENT Beckman-Diagnostic Systems Group KHP Class I 1993-11-09
K932727 CHOLESTECH L.D.X. SYSTEM Cholestech Corp. CGA Class II 1993-11-09
K931698 KINGS BAY PRELUDE ONE STEP HCG COMBO KIT King'S Bay Intl., Inc. JHI Class II 1993-11-05
K931080 AMYLASE REAGENT SET (KINETIC) Teco Diagnostics JFJ Class II 1993-11-05
K934143 N-ASSAY TIA MICROALBUMIN CALIBRATOR SET Crestat Diagnostics, Inc. JIX Class II 1993-11-05
K933128 SYNELISA PROGESTERONE Elias U.S.A., Inc. JLS Class I 1993-11-05
K933142 ACCESS VITAMIN B12 ASSAY Bio-Rad Laboratories, Inc. CDD Class II 1993-11-05
K932467 ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM Instrumentation Laboratory CO JJQ Class I 1993-11-05
K934136 OLYMPUS CHLORIDE REAGENT, MODIFICATION Olympus Corp. CHJ Class II 1993-11-05
K933548 ELS 1000 Bio-Tek Instruments, Inc. JJE Class I 1993-10-29
K933397 GENZYME A-AMYLASE TEST REAGENT Genzyme Corp. JFJ Class II 1993-10-28
K931559 DMA AMYLASE PROCEDURE Data Medical Associates, Inc. CIW Class II 1993-10-28
K933026 SYNERMED DIRECT BILIRUBIN REAGENT KIT Synermed, Inc. CIG Class II 1993-10-28
K934046 BECKMAN CHOLESTEROL REAGENT Beckman-Diagnostic Systems Group CHH Class I 1993-10-28
K932660 LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 More Diagnostics JJX Class I 1993-10-28
K933437 DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3 Baxter Diagnostics, Inc. JJY Class I 1993-10-28
K932442 CARDIO REP RECOMBINANT CK ABNORMAL CONTROL Helena Laboratories JJT Class I 1993-10-28
K932912 STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC Baxter Diagnostics, Inc. CEC Class II 1993-10-28
K933695 SIGMA ELECTROLYTE BUFFER Sigma Chemical Co. JFL Class II 1993-10-22
K933329 KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT King Diagnostics, Inc. JMO Class I 1993-10-22
K931228 PROGESTERONE RADIOIMMUNOASSAY KIT Immunotech Corp. JLS Class I 1993-10-22
K933464 STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Diagnostics, Inc. CHP Class I 1993-10-22
K933269 AIA-PACK(R) PROG ASSAY Tosoh Medics, Inc. JLS Class I 1993-10-22
K934121 VISTA FOLATE ASSAY Syva Co. CGN Class II 1993-10-22
K934357 LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2 Bio-Rad JJY Class I 1993-10-21
K932768 CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323 Helena Laboratories JIX Class II 1993-10-18
K932980 TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 Sigma Diagnostics, Inc. CDX Class II 1993-10-18
K931301 OLYMPUS AMYLASE REAGENT Olympus Corp. CIJ Class II 1993-10-18
K934056 TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3 Medical Analysis Systems, Inc. JJY Class I 1993-10-18
K933697 SIGMA CRE REAGENT Sigma Chemical Co. CGX Class II 1993-10-18
K932642 AVL 9110PH ANALYZER Avl Scientific Corp. CHL Class II 1993-10-14
K934045 BECKMAN HDL CHOLESTEROL REAGENT Beckman Instruments, Inc. LBS Class I 1993-10-14
K934042 CHEMSTRIP SUPER UA URINE ANALYZER Boehringer Mannheim Corp. KQO Class I 1993-10-14
K933955 DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM E.I. Dupont DE Nemours & Co., Inc. JIX Class II 1993-10-13
K933693 SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 Sigma Chemical Co. JIX Class II 1993-10-13
K933386 VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic GIM Class II 1993-10-12
K921536 ACCULYTE CHEMILUMINESCENCE ANALYZER Laboratory Technologies, Inc. JJQ Class I 1993-10-12
K931402 IL TEST GLUCOSE Instrumentation Laboratory CO CFR Class II 1993-10-12
K932887 ACCESS FOLATE ASSAY Beckman Coulter, Inc. CGN Class II 1993-10-12
K933862 ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE) Schiapparelli Biosystems, Inc. JGS Class II 1993-10-12
K933702 SIGMA CX-3 CALIBRATION STANDARD LEVEL 1 Sigma Chemical Co. JIX Class II 1993-10-08
K933635 STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY Baxter Diagnostics, Inc. JLS Class I 1993-10-08
K933571 RADIAS FOLATE ENZYME IMMUNOASSAY Bio-Rad CGN Class II 1993-10-01
K931350 IL TEST URIC ACID Instrumentation Laboratory CO KNK Class I 1993-10-01
K931907 ANTHOS HT READERS, INCLUDING THE ANTHOS HT II&III Anthos Labtec Instruments JJQ Class I 1993-09-29
K931368 MICROTAINER BRAND TUBE WITH EDTA Bd Becton Dickinson Vacutainer Systems Preanalytic JKA Class II 1993-09-28
K932758 MEDIX BIOTECH BESTEST HCG-URINE TEST KIT Medix Biotech, Inc. JHI Class II 1993-09-28
K923506 UREA KIT Randox Laboratories, Ltd. CDQ Class II 1993-09-27
K932158 CALCIUM TEST ITEM NUMBER 65409 Em Diagnostic Systems, Inc. CIC Class II 1993-09-27
K931177 SYNELISA CORTISOL Elias U.S.A., Inc. CGR Class II 1993-09-27
K932162 URIC ACID TEST ITEM NUMBER 65422 Em Diagnostic Systems, Inc. CDO Class I 1993-09-27
K933435 DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2 Baxter Diagnostics, Inc. JJY Class I 1993-09-24
K933744 SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES Sa Scientific, Inc. JJX Class I 1993-09-24
K932267 ENZYMATIC CO2 REAGENT, MODIFICATION Intersect Systems, Inc. KHS Class II 1993-09-24
K932178 AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES Tosoh Medics, Inc. JJX Class I 1993-09-21
K931786 ACE CLINICAL CHEMISTRY SYSTEM Schiapparelli Biosystems, Inc. JJE Class I 1993-09-21
K931939 OLYMPUS CREATININE REAGENT Olympus Corp. CGX Class II 1993-09-21

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