meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
62
Latest Decision
1989-02-10

Clearances · page 75 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K884547 CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673 Em Diagnostic Systems, Inc. CGS Class II 1989-02-10
K884864 PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO The Perkin-Elmer Corp. JJQ Class I 1989-02-10
K890304 IRON REAGENTS ITEM NUMBER: SR1017 Em Diagnostic Systems, Inc. JIY Class I 1989-02-10
K885195 AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT Amersham Corp. CDP Class II 1989-02-08
K885266 OLYMPUS TRIGLYCERIDES REAGENTS #SR1021 Em Diagnostic Systems, Inc. CDT Class I 1989-02-07
K885289 KODAK EKTACHEM 700 ANALYZER FAMILY, SOFT V5.0 Eastman Kodak Company JJE Class I 1989-02-07
K885288 HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE Eastman Kodak Company JJE Class I 1989-02-07
K890184 MODIFIED INTENDED USE OF CLEANING REAGENT KIT Hichem Diagnostics JJE Class I 1989-02-07
K883170 STANBIO MAGNESIUM TEST SET, CAT. NO 0130 Stanbio Laboratory JGJ Class I 1989-02-07
K890183 MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL. Hichem Diagnostics JJE Class I 1989-02-07
K885193 OLYMPUS ISE MODULE Olympus Corp. CGZ Class II 1989-02-03
K884731 LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ Amdev, Inc. JFP Class II 1989-02-03
K890034 PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) American Monitor Corp. JIY Class I 1989-02-03
K885034 T-UPTAKE MICROASSAY Diamedix Corp. CEE Class II 1989-02-02
K884886 MODEL 250 LIQUID CHROMOTAGRAPHY PUMP The Perkin-Elmer Corp. LDM Class I 1989-02-02
K884546 CREATINE KINASE TEST (CK) ITEM NUMBER: 65661 Em Diagnostic Systems, Inc. CGS Class II 1989-02-02
K884794 PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. JLS Class I 1989-02-02
K885156 CLINISTAT SGOT (AST) REAGENT TEST Heraeus Kulzer, Inc. CIT Class II 1989-02-02
K882262 GLUCOSE-SUPER FAST 4983050 AND 4983500 American Research Products Co. CGA Class II 1989-02-02
K884091 SOURCERER John Caunt Scientific , Ltd. JJJ Class I 1989-02-02
K885144 CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN Heraeus Kulzer, Inc. CKA Class I 1989-02-02
K884748 TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) Technicon Instruments Corp. JFH Class II 1989-01-30
K885285 DIRECT BILIRUBIN TEST CATALOG NO. SR1008 Em Diagnostic Systems, Inc. CIG Class II 1989-01-30
K885053 BIOTROL URINE PROTEINS REAGENT Biotrol, USA, Inc. JIR Class I 1989-01-30
K885284 TOTAL BILIRUBIN TEST CATALOG NO. SR1007 Em Diagnostic Systems, Inc. CIG Class II 1989-01-30
K885041 BIOTROL INORGANIC PHOSPHORUS Biotrol, USA, Inc. CEO Class I 1989-01-30
K883430 PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST Disease Detection International, Inc. LCX Class II 1989-01-30
K884747 TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) Technicon Instruments Corp. CKB Class II 1989-01-30
K885254 TARGET READER V-Tech, Inc. JQT Class I 1989-01-27
K871115 UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON. Labo Science-USA, Inc. CIG Class II 1989-01-27
K883967 BECKMAN LIQUID-STAT MAGNESIUM REAGENT & STANDARD Beckman Instruments, Inc. JGJ Class I 1989-01-27
K884599 TECHNICON RA-100 SYSTEM CALCIUM METHOD Technicon Instruments Corp. CIC Class II 1989-01-27
K884807 LIPOCLEAR LIPEMIA CLEARING REAGENT Statspin Technologies JKA Class II 1989-01-27
K884700 ANALYST THYROXINE (T4) ROTOR The DU Pont Co. KLI Class II 1989-01-27
K884601 TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE Technicon Instruments Corp. CHJ Class II 1989-01-27
K884977 GAS TRAK PLUS United Diagnostics, Inc. JJY Class I 1989-01-27
K884169 DU PONT ANALYST THYROID ROTOR The DU Pont Co. CEL Class I 1989-01-24
K884704 URIC ACID TEST (URIC) ITEM #65620 Em Diagnostic Systems, Inc. KNK Class I 1989-01-23
K884146 ALBUWELL Exocell, Inc. JIR Class I 1989-01-23
K883327 CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST Heraeus Kulzer, Inc. JGZ Class II 1989-01-23
K884600 TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM Technicon Instruments Corp. JGJ Class I 1989-01-23
K884703 TOTAL PROTEIN TEST (TP) ITEM #65670 Em Diagnostic Systems, Inc. CEK Class II 1989-01-23
K884708 FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT Cyberfluor, Inc. CGJ Class I 1989-01-17
K884769 MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY Ciba Corning Diagnostics Corp. CEM Class II 1989-01-17
K885022 MAGNESIUM TEST ITEM NUMBER: SR1019 Em Diagnostic Systems, Inc. JGJ Class I 1989-01-17
K884756 CLINISTAT GLUCOSE REAGENT TEST Heraeus Kulzer, Inc. CGA Class II 1989-01-13
K884987 UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022 Em Diagnostic Systems, Inc. CDQ Class II 1989-01-13
K882344 ELECTR-TRANSBLOTTER The W.E.P. Co. JJN Class I 1989-01-13
K884986 CALCIUM TEST ITEM NUMBER: SR1009 Em Diagnostic Systems, Inc. CIC Class II 1989-01-13
K884616 FIRSTDAY EARLY PREGNANCY TESTING KIT II Pacific Biotech, Inc. JHI Class II 1989-01-13
K884988 GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664 Em Diagnostic Systems, Inc. JQB Class I 1989-01-13
K884880 PREGNAGEN(TM) Biogenex Laboratories JHI Class II 1989-01-13
K884706 CHLORIDE TEST (CL) ITEM #65659 Em Diagnostic Systems, Inc. CHJ Class II 1989-01-11
K884382 AMYLASE TEST (AMYL) ITEM NUMBER: 65653 Em Diagnostic Systems, Inc. CIW Class II 1989-01-11
K884705 ALBUMIN TEST (ALB) ITEM #65650 Em Diagnostic Systems, Inc. CIX Class II 1989-01-11
K884376 ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652 Em Diagnostic Systems, Inc. CKA Class I 1989-01-11
K884189 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC) Eastman Kodak Company KHP Class I 1989-01-11
K884269 SAMPLE IDENTIFICATION STATION MODEL 38010 Icn Micromedic Systems JJJ Class I 1989-01-09
K884124 AUTOMATED EIA READER MODEL EL311 Bio-Tek Instruments, Inc. JJQ Class I 1989-01-03
K884736 GLUCOSE-HK TEST (GLUC-HK) ITEM #65665 Em Diagnostic Systems, Inc. CFR Class II 1989-01-03
K884909 GLUCOSE LIQUID AMRESCO #4628300 & 4628001L American Research Products Co. CGA Class II 1989-01-03
K883742 MODIFIED TSH IRMA KIT Pacific Biotech, Inc. JLW Class II 1989-01-03
K884936 ALANINE AMINOTRANSFERASE Catachem, Inc. CKA Class I 1989-01-03
K882225 -AMYLASE EPS Boehringer Mannheim Corp. CIJ Class II 1989-01-03
K884035 SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER Sclavo, Inc. JJE Class I 1988-12-29
K884784 VIRGO(R) MICROWELL ALT ASSAY Electro-Nucleonics, Inc. CKD Class I 1988-12-29
K884993 VISUAL BLOOD GLUCOSE TEST SYSTEM Diagnostic Systems CGA Class II 1988-12-29
K884821 ABBOTT SPECTRUM(R) BICARBONATE REAGENT Abbott Laboratories KHS Class II 1988-12-27
K883123 AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT Amersham Corp. CEC Class II 1988-12-22
K884403 LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE Supelco, Inc. DPM Class I 1988-12-22
K884498 COTUBE LH IRMA ASSAY Bio-Rad CEP Class I 1988-12-22
K883530 FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST Tambrands, Inc. CEP Class I 1988-12-19
K884734 CREATININE TEST (CREA) ITEM #65663 Em Diagnostic Systems, Inc. CGX Class II 1988-12-19
K884735 PHOSPHORUS TEST (PHOS) ITEM #65666 Em Diagnostic Systems, Inc. CEO Class I 1988-12-16
K883615 LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 Supelco, Inc. DJY Class I 1988-12-16
K883543 HDL-CHOLESTEROL PRECIPITATING REAGENT Medical Analysis Systems, Inc. CHH Class I 1988-12-16
K884355 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE) Eastman Kodak Company JIY Class I 1988-12-16
K884693 UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS Biomedical Research & Development Laboratories, Inc. JIX Class II 1988-12-15
K883726 THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL Immuchem Corp. JLW Class II 1988-12-15
K884224 TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS A-Kem, Inc. CIG Class II 1988-12-15
K884424 LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) Bio-Rad JJW Class I 1988-12-15
K883533 ABC FP ANALYZER Intl. Bioclinical, Inc. JJE Class I 1988-12-15
K884111 PUMPETTE(TM) Helena Laboratories JKA Class II 1988-12-14
K883559 DELFIA THYROXINE (T4) KIT Pharmacia, Inc. CDX Class II 1988-12-14
K884377 ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654 Em Diagnostic Systems, Inc. CIT Class II 1988-12-14
K883389 RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD Reagents Applications, Inc. JIW Class II 1988-12-14
K884197 DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET Casco Standards JIT Class II 1988-12-14
K884201 FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT Cyberfluor, Inc. CEE Class II 1988-12-14
K884649 TOTAL IRON BINDING CAPACITY TEST Sclavo, Inc. JQE Class I 1988-12-14
K883817 ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM Boehringer Mannheim Corp. CGA Class II 1988-12-09
K884430 SERUM HCG MICROASSAY Diamedix Corp. DHA Class II 1988-12-09
K884225 TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS A-Kem, Inc. CEK Class II 1988-12-09
K883470 IDS-1600 SAMPLE HANDLING SYSTEM Baxter Healthcare Corp JQW Class I 1988-12-09
K884013 ROCHE REAGENT FOR CHLORIDE Roche Diagnostic Systems, Inc. CHJ Class II 1988-12-09
K884634 MODIFIED CEDIA TOTAL T4 ASSAY Microgenics Corp. KLI Class II 1988-12-09
K884227 CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM A-Kem, Inc. JIX Class II 1988-12-09
K884226 AMYLASE REAGENT KIT FOR ASTRA SYSTEMS A-Kem, Inc. CJA Class II 1988-12-09
K884596 ABBOTT A-GENT LIPASE REAGENT Abbott Laboratories CHI Class I 1988-12-06
K884687 CIBA CORNING MAGIC LITE FSH IMMUNOASSAY Ciba Corning Diagnostics Corp. CGJ Class I 1988-12-06
K883148 IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40 Diagnostic Chemicals, Ltd. (Usa) DHA Class II 1988-12-05

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