meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
46
Latest Decision
1999-02-03

Clearances · page 38 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K982298 OPTICOAT T4 EIA KIT Biotecx Laboratories, Inc. KLI Class II 1999-02-03
K984594 LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 Bio-Rad JJY Class I 1999-02-02
K984625 ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 Bio-Rad JJX Class I 1999-02-02
K984437 QUANTEX ASO-CRP-RP CONTROL II Instrumentation Laboratory CO JJT Class I 1999-02-02
K984604 ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 Bio-Rad JJX Class I 1999-02-02
K984419 ELECSYS IGE CALCHECK Boehringer Mannheim Corp. JJY Class I 1999-02-02
K982307 WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 Wallac, Inc. JNB Class II 1999-02-02
K983457 OSTEOMARK NTX SERUM EIA Ostex Intl., Inc. JMM Class I 1999-02-02
K982328 BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. CJO Class II 1999-01-29
K984626 ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 Bio-Rad JJX Class I 1999-01-29
K990092 AVL OMNI MODULAR ANALYZER Avl Scientific Corp. CHL Class II 1999-01-29
K984402 SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT Beckman Coulter, Inc. JIF Class I 1999-01-29
K983674 VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS Ortho-Clinical Diagnostics, Inc. JMM Class I 1999-01-29
K984477 LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529 Bio-Rad JJY Class I 1999-01-29
K990026 VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. JJX Class I 1999-01-29
K990161 ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01 Bio-Rad JJY Class I 1999-01-28
K983774 UALB Abbott Laboratories JIR Class I 1999-01-28
K984107 RDI DIRECT LDL CHOLESTEROL TEST Reference Diagnostics, Inc. MRR Class I 1999-01-28
K990162 ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01 Bio-Rad JJX Class I 1999-01-28
K984303 VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT Ortho-Clinical Diagnostics, Inc. LBR Class I 1999-01-28
K990150 ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01 Bio-Rad JJY Class I 1999-01-26
K990149 ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01 Bio-Rad JJY Class I 1999-01-26
K990061 VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. JJX Class I 1999-01-25
K990017 ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10 Bio-Rad JJY Class I 1999-01-25
K984321 VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS Ortho-Clinical Diagnostics, Inc. CDD Class II 1999-01-22
K984425 MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR Boehringer Mannheim Corp. JIX Class II 1999-01-20
K984122 WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR Wako Chemicals USA, Inc. JQF Class I 1999-01-20
K984119 WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR Wako Chemicals USA, Inc. CFM Class I 1999-01-15
K984361 ORAL-EZE ORAL FLUID COLLECTION SYSTEM Osborn Laboratories, Inc. PJD Class II 1999-01-13
K984067 STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK Dade Behring, Inc. JHX Class II 1999-01-13
K984184 WAKO L-TYPE AMYLASE Wako Chemicals USA, Inc. JFJ Class II 1999-01-13
K990024 CARESIDE ALKALINE PHOSPHATASE Careside, Inc. CJE Class II 1999-01-13
K983849 DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE Dade Behring, Inc. JHM Class I 1999-01-11
K983937 DUAL VIAL CREATININE REAGENT Intersect Systems, Inc. CGX Class II 1999-01-06
K982928 NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM Radiometer America, Inc. CHL Class II 1999-01-06
K983990 VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY Ortho-Clinical Diagnostics, Inc. CGR Class II 1998-12-29
K983952 GREINER VACUETTE BLOOD COLLECTION TUBE Greiner Meditech, Inc. JKA Class II 1998-12-28
K984359 AIA-PACK TROPONIN I ASSAY Tosoh Medics, Inc. MMI Class II 1998-12-23
K984384 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 Thermo Bioanalysis Corp. CHL Class II 1998-12-23
K984014 SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 Beckman Coulter, Inc. JIX Class II 1998-12-23
K972788 CROSSLAPS ELISA Devices and Diagnostics Consulting Group JMM Class I 1998-12-22
K981824 OPTICOAT T3 EIA KIT Biotecx Laboratories, Inc. CDP Class II 1998-12-22
K984327 ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 Bio-Rad JJX Class I 1998-12-22
K984319 ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 Bio-Rad JJX Class I 1998-12-22
K983640 SYNCHRON SYSTEMS LIPID CALIBRATOR Beckman Coulter, Inc. JIS Class II 1998-12-21
K984325 ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 Bio-Rad JJY Class I 1998-12-17
K983432 SUPREME II CONTROL SOLUTIONS Chronimed, Inc. JJX Class I 1998-12-17
K983789 CARESIDE CALCIUM, ORIGINAL Careside, Inc. CJY Class II 1998-12-17
K983468 FASTTAKE ADAPTER, MODEL # P/N 020-072-01 Selfcare, Inc. JQP Class I 1998-12-17
K983807 LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 Bio-Rad JJY Class I 1998-12-16
K984324 ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 Bio-Rad JJX Class I 1998-12-15
K984323 ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 Bio-Rad JJX Class I 1998-12-15
K984318 ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 Bio-Rad JJX Class I 1998-12-15
K984193 DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR Dade Behring, Inc. JIT Class II 1998-12-14
K984225 LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 Bio-Rad JJY Class I 1998-12-14
K984093 STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK Dade Behring, Inc. MMI Class II 1998-12-14
K984372 ELECSYS CALCHECK TROPONIN T Boehringer Mannheim Corp. JJY Class I 1998-12-14
K984299 AVL OPTI CRITICAL CARE ANALYZER Avl Scientific Corp. JFP Class II 1998-12-11
K982076 AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM Amira Medical, Inc. CGA Class II 1998-12-10
K984277 CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 Medical Analysis Systems, Inc. JJT Class I 1998-12-09
K984105 ELECSYS TROPONIN T STAT TEST Boehringer Mannheim Corp. MMI Class II 1998-12-08
K982303 PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST Medisense, Inc. CGA Class II 1998-12-08
K984011 VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. JJX Class I 1998-12-07
K983345 BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY Bayer Corp. JJE Class I 1998-12-07
K983972 IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 Diagnostic Products Corp. MMI Class II 1998-12-07
K984071 LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 Bio-Rad JJX Class I 1998-12-03
K983503 ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 Boehringer Mannheim Corp. CEO Class I 1998-12-01
K983424 ABBOTT ARCHEITECT TOTAL B-HCG Abbott Laboratories DHA Class II 1998-12-01
K983490 TERUMO VENOJECT,LUER ADAPTER Terumo Corp. JKA Class II 1998-11-30
K983440 ABBOTT ARCHITECT TOTAL T4 Abbott Laboratories KLI Class II 1998-11-25
K983469 PRECISET SERUM PROTEINS CALIBRATOR Boehringer Mannheim Corp. JIX Class II 1998-11-25
K984073 ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05 Bio-Rad JJX Class I 1998-11-25
K984070 ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05 Bio-Rad JJX Class I 1998-11-25
K984072 ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05 Bio-Rad JJX Class I 1998-11-24
K984074 ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05 Bio-Rad JJY Class I 1998-11-20
K983434 ABBOTT ARCHITECT TOTAL T3 Abbott Laboratories CDP Class II 1998-11-20
K983439 ABBOTT ARCHITECT FREE T3 Abbott Laboratories CDP Class II 1998-11-20
K983442 ABBOTT ARCHITECT TSH Abbott Laboratories JLW Class II 1998-11-20
K983417 ABBOTT ARCHITECT FREE T4 Abbott Laboratories CEC Class II 1998-11-20
K983212 ABBOTT ARCHITECT TESTOSTERONE Abbott Laboratories CDZ Class I 1998-11-18
K983971 CARDIAC MARKER CONTROL MODULE, MODEL CCCM Diagnostic Products Corp. JJX Class I 1998-11-18
K983113 BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT Syntron Bioresearch, Inc. CEP Class I 1998-11-18
K983090 ACON MIDSTREAM PREGNANCY TEST ACON Laboratories, Inc. LCX Class II 1998-11-18
K983850 DIMENSION AHDL CALIBRATOR Dade Behring, Inc. JIT Class II 1998-11-18
K983617 25-HYDROXYVITAMIN D 125I RIA KIT DiaSorin, Inc. LCI Class I 1998-11-16
K983578 ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 Bio-Rad JJX Class I 1998-11-12
K983517 SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM Ram Scientific JKA Class II 1998-11-12
K983507 VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY Ortho-Clinical Diagnostics, Inc. JJY Class I 1998-11-04
K983304 SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT Synermed Intl., Inc. CIG Class II 1998-11-04
K983722 STRATUS CS TROPONIN I CALIBRATOR Dade Behring, Inc. JIT Class II 1998-11-04
K983693 DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR Dade Behring, Inc. JIT Class II 1998-11-04
K983513 VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. JJY Class I 1998-11-03
K981207 CLEARPLAN EASY FERTILITY MONITOR Unipath , Ltd. NGE Class I 1998-10-28
K983510 CHEMSTRIP 101 URINE ANALYZER Boehringer Mannheim Corp. KQO Class I 1998-10-27
K983548 FERRITIN CALIBRATOR Dade Behring, Inc. JIT Class II 1998-10-27
K981791 MG Abbott Laboratories JGJ Class I 1998-10-23
K983416 ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 Boehringer Mannheim Corp. JGJ Class I 1998-10-21
K982998 GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE Greiner Meditech, Inc. JKA Class II 1998-10-21
K982999 GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE Greiner Meditech, Inc. JKA Class II 1998-10-16
K980907 AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY Axis Biochemicals, Asa LPS Class II 1998-10-16

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