meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
58
Latest Decision
1997-04-23

Clearances · page 44 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K971071 LIQUID LIGAND 1,2,3 Chiron Diagnostics Corp. JJY Class I 1997-04-23
K970985 WAKO TOTAL BILIRUBIN V Wako Chemicals USA, Inc. JFM Class II 1997-04-21
K971363 SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT Carolina Liquid Chemistries Corp. CEO Class I 1997-04-21
K971344 AST OR SGOT Carolina Liquid Chemistries Corp. CIT Class II 1997-04-21
K970314 SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS Beckman Instruments, Inc. MSJ Class I 1997-04-21
K971323 ALT OR SGPT Carolina Liquid Chemistries Corp. CKA Class I 1997-04-21
K970781 LIQUID GLUCOSE (OXIDASE) REAGENT SET Pointe Scientific, Inc., CGA Class II 1997-04-21
K970867 URIC ACID REAGENT Derma Media Lab., Inc. KNK Class I 1997-04-21
K970616 MINI SAMPLER PROCESSOR Cavro Scientific Instruments, Inc. JQW Class I 1997-04-21
K971005 TRIGLYCERIDES Derma Media Lab., Inc. JGY Class I 1997-04-21
K965035 IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT Beckman Instruments, Inc. JIQ Class I 1997-04-17
K970778 LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 More Diagnostics JJX Class I 1997-04-17
K970894 VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) Johnson & Johnson Clinical Diagnostics, Inc. DHA Class II 1997-04-14
K970330 DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE Dade Intl., Inc. CEM Class II 1997-04-14
K970483 AQUALITE INTACT PTH Sealite Sciences, Inc. CEW Class II 1997-04-14
K971133 URIC, UA, OR URIC ACID Carolina Liquid Chemistries Corp. KNK Class I 1997-04-14
K971051 IMMULITE THYROID AUTOANTIBODY CONTROL MODULE Diagnostic Products Corp. JJX Class I 1997-04-10
K970250 CLINISTRIP Teco Diagnostics JIL Class II 1997-04-08
K970921 STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) Alko Diagnostic Corp. JIX Class II 1997-04-08
K970856 CARDIOISOZYME, CK/LD ISOENZYME CONTROL Medical Analysis Systems, Inc. JJT Class I 1997-04-08
K970227 IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER Dpc Cirrus JJE Class I 1997-04-08
K970956 CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 Chiron Diagnostics Corp. JJY Class I 1997-04-08
K970862 SPINALSCOPICS Quantimetrix Corp. JJY Class I 1997-04-08
K962208 NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT Nichols Institute Diagnostics CGR Class II 1997-04-08
K970932 ORGENTEC MICRO-ALBUMIN EIA ASSAY American Laboratory Products Co., Ltd. JIR Class I 1997-04-08
K971209 CLINITEK HCG TEST STRIPS Bayer Corp. JHI Class II 1997-04-04
K970984 THE ELECSYS CALCHECK PROGESTERONE Boehringer Mannheim Corp. JJX Class I 1997-04-02
K970701 DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) Diagnostic Systems Laboratories, Inc. CFL Class I 1997-04-02
K970976 CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 Medical Analysis Systems, Inc. JJY Class I 1997-04-02
K970979 LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 Chiron Diagnostics Corp. JJY Class I 1997-04-02
K962687 GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM Nichols Institute Diagnostics JQW Class I 1997-03-28
K964346 PARAMAX TRIGLYCERID REAGENT Dade Intl., Inc. CDT Class I 1997-03-28
K964915 MAGNESIUM Derma Media Lab., Inc. JGJ Class I 1997-03-26
K970539 CHIRON DIAGNOSTICS ACS:180TU P Chiron Diagnostics Corp. KHQ Class II 1997-03-24
K964841 ELECSYS PROGESTERONE ASSAY Boehringer Mannheim Corp. JLS Class I 1997-03-24
K965186 AXSYM B12 Abbott Laboratories CDD Class II 1997-03-24
K970120 BILE ACIDS REAGENT SET Teco Diagnostics KWW Class II 1997-03-24
K963268 GENESIS RMP Tecan U.S., Inc. JRA Class I 1997-03-18
K970467 EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT Excel Scientific, Inc. CEP Class I 1997-03-18
K965142 VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) Johnson & Johnson Clinical Diagnostics, Inc. CEC Class II 1997-03-18
K962408 NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT Nichols Institute Diagnostics CEC Class II 1997-03-18
K970643 VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) Johnson & Johnson Clinical Diagnostics, Inc. CHP Class I 1997-03-18
K964889 ELECSYS TESTOSTERONE ASSAY Boehringer Mannheim Corp. CDZ Class I 1997-03-18
K962723 TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN Trace America, Inc. LBR Class I 1997-03-13
K970560 URIC ACID (LIQUID) REAGENT SET Pointe Scientific, Inc., KNK Class I 1997-03-11
K965058 NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT Nichols Institute Diagnostics CDP Class II 1997-03-11
K965240 SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L Beckman Instruments, Inc. JJE Class I 1997-03-10
K970387 HUMAN CHORIONIC GONADOTROPIN METHOD Dade Chemistry Systems, Inc. DHA Class II 1997-03-10
K970477 HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT Sebia CFE Class II 1997-03-10
K970357 EPISCREEN Epitope, Inc. PJD Class II 1997-03-10
K970100 TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL Simplicity Diagnostics, Inc. MJX Class I 1997-03-10
K970087 CR PERFECT Chimera Research & Chemical, Inc. CGX Class II 1997-03-06
K970459 ELECSYS CALCHECK CEA Boehringer Mannheim Corp. JJX Class I 1997-03-06
K970458 ELECSYS CALCHECK PSA Boehringer Mannheim Corp. JJX Class I 1997-03-06
K970425 EZ SURE URINE DIPSTICK PREGNANCY HOME TEST Excel Scientific, Inc. LCX Class II 1997-03-06
K970452 ELECSYS CALCHECK CEA Boehringer Mannheim Corp. JJX Class I 1997-03-06
K970424 EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST Excel Scientific, Inc. JHI Class II 1997-03-06
K970124 LIPASE REAGENT SET (COLIPASE METHOD) Teco Diagnostics CET Class I 1997-03-06
K970393 THYROID STIMULATING HORMONE METHOD Dade Chemistry Systems, Inc. JLW Class II 1997-03-03
K970336 MMB CALIBRATOR Dade Chemistry Systems, Inc. JIT Class II 1997-03-03
K964698 SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT Andwin Scientific JKA Class II 1997-03-03
K970527 ABBOTT HCG SERUM CONTROLS Abbott Laboratories JJX Class I 1997-03-03
K962479 SYNERMED ISE REAGENTS Synermed, Inc. CGZ Class II 1997-03-03
K970126 ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) Bio-Rad Laboratories, Inc. CHP Class I 1997-02-25
K970281 VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS Johnson & Johnson Clinical Diagnostics, Inc. CFT Class I 1997-02-25
K964982 VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) Johnson & Johnson Clinical Diagnostics, Inc. CEP Class I 1997-02-20
K970396 HUMAN CHORIONIC GONADOTROPIN CALIBRATOR Dade Chemistry Systems, Inc. JIW Class II 1997-02-20
K964633 ACCUPACK PREGNANCY TEST Genix Biotek, Inc. JHI Class II 1997-02-20
K970188 SEALITE SCIENCES, INC. AQUALITE PROLACTIN Sealite Sciences, Inc. CFT Class I 1997-02-20
K965036 THE ADVANCED OSMOMETER (3900) Advanced Instruments, Inc. JJM Class I 1997-02-20
K964913 IRON REAGENT Derma Media Lab., Inc. JIY Class I 1997-02-20
K965114 TUMOR MARKER CONTROL Diagnostic Products Corp. JJY Class I 1997-02-20
K963676 PRECISION G BLOOD GLUCOSE TESTING SYSTEM Medisense, Inc. CGA Class II 1997-02-20
K963544 SUPREME II METER Chronimed, Inc. CGA Class II 1997-02-20
K965116 ABBOTT TESTPACK PLUS HCG COMBO WITH OBC Abbott Laboratories JHI Class II 1997-02-20
K965253 SAS PREGNANCY STRIP Sascie JHI Class II 1997-02-18
K965109 ELECSYS ESTRADIOL ASSAY Boehringer Mannheim Corp. CHP Class I 1997-02-18
K963640 OLYMPUS ACID PHOSPHATASE REAGENT Olympus America, Inc. CKB Class II 1997-02-18
K970008 ADVANCED QUALITY PREGNANCY TEST Bionike, Inc. LCX Class II 1997-02-18
K965250 SAS SERUM/URINE HCG Sascie JHI Class II 1997-02-18
K965134 ALT/SGPT Derma Media Lab., Inc. CKA Class I 1997-02-18
K970389 THYROID CALIBRATOR Dade Chemistry Systems, Inc. JIT Class II 1997-02-18
K961142 STRATEC LIA II ANALYZER Nichols Institute Diagnostics JJE Class I 1997-02-18
K964960 VITROS CHEMISTRY PRODUCTS UPRO SLIDES Johnson & Johnson Clinical Diagnostics, Inc. JGP Class II 1997-02-18
K970343 MMB METHOD Dade Chemistry Systems, Inc. JHY Class II 1997-02-14
K970085 SEALITE SCIENCES AQUALITE FSH Sealite Sciences, Inc. CGJ Class I 1997-02-14
K970248 CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM Canyon Diagnostics, Inc. JQE Class I 1997-02-11
K964462 ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST Teco Diagnostics JHI Class II 1997-02-11
K964461 ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST Teco Diagnostics JHI Class II 1997-02-11
K964536 ONE-STEP DIPSTICK PREGNANCY TEST Teco Diagnostics JHI Class II 1997-02-11
K964010 IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT Beckman Instruments, Inc. MSJ Class I 1997-02-10
K964630 GLUCOMETER ELITE BLOOD GLUCOSE METER Bayer Corp. CGA Class II 1997-02-10
K964004 GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS Bayer Corp. CFR Class II 1997-02-10
K970148 ELECSYS CALCHECK ESTRADIOL Boehringer Mannheim Corp. JJX Class I 1997-02-10
K970147 ELECSYS CALCHECK PROLACTIN Boehringer Mannheim Corp. JJY Class I 1997-02-10
K964862 TROPONIN-I TEST SYSTEM Dade Intl., Inc. MMI Class II 1997-02-10
K965202 VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET Bd Becton Dickinson Vacutainer Systems Preanalytic JKA Class II 1997-02-10
K964372 CARDIAC T TROPONIN T RAPID ASSAY Boehringer Mannheim Corp. MMI Class II 1997-02-10
K962718 FEMEXAM TESTCARD Litmus Concepts, Inc. CEN Class I 1997-02-07
K970176 HCG CONTROLS International Newtech Development, Inc. JJX Class I 1997-02-06

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