meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
55
Latest Decision
1996-04-30

Clearances · page 48 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K961441 TONOMETERED SLAINE BLOOD GAS CONTROL Instrumentarium Corp. JJS Class I 1996-04-30
K960316 CLEARBLUE EASY Unipath , Ltd. LCX Class II 1996-04-29
K961161 AVL OPTI 1 PH/BLOOD GAS ANALYZER Avl Scientific Corp. CHL Class II 1996-04-26
K960103 DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS Dade Intl., Inc. JIX Class II 1996-04-26
K960561 DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 Diagnostic Systems Laboratories, Inc. CFT Class I 1996-04-26
K960992 BIONIKE A/Q PREGNANCY TEST Bionike Laboratories, Inc. JHI Class II 1996-04-25
K961123 ALT INCORPORATING DST Trace Scientific , Ltd. CKA Class I 1996-04-25
K960275 OPUS CK-MB & TOTAL CK CONTROLS Behring Diagnostics, Inc. JJT Class I 1996-04-25
K955690 AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 Clinical Controls, Inc. JJY Class I 1996-04-24
K951222 TOTAL PROTEIN (URINE) Randox Laboratories, Ltd. JIR Class I 1996-04-24
K955691 SERUM VOLATILES CONTROL LEVEL 1 & 2 Clinical Controls, Inc. JJY Class I 1996-04-24
K960246 LIQUID CARDIAC MARKER 1,2,3 ASSAYED Ciba Corning Diagnostics Corp. JJT Class I 1996-04-23
K960824 IMMUNOLOGY CONTROL Medical Analysis Systems, Inc. JJY Class I 1996-04-23
K961172 DSL ACTIVE NON-EXTRACTION IGF-I IRMA Diagnostic Systems Laboratories, Inc. CFL Class I 1996-04-23
K961206 OPUS T3 CONTROLS Behring Diagnostics, Inc. JJX Class I 1996-04-23
K960233 MINICLINIC OVULATION PREDICTOR Vanguard Biomedical Corp. CEP Class I 1996-04-23
K944459 ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM Boehringer Mannheim Corp. CGA Class II 1996-04-17
K932661 WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 Whatman Specialty Products, Inc. PJC Class II 1996-04-17
K960195 THYROCHEK ONE-STEP RAPID TSH ASSAY Franklin Diagnostics, Inc. JLW Class II 1996-04-15
K960035 CARBON DIOXIDE - DST Trace America, Inc. KHS Class II 1996-04-08
K953971 TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY Trace America, Inc. CDT Class I 1996-04-05
K961109 ACTIVE LH IRMA Diagnostic Systems Laboratories, Inc. CEP Class I 1996-04-05
K960084 HICHEM GLUCOSE/HK REAGENT KIT Hi Chem, Inc. CFR Class II 1996-04-04
K960862 LIPID CONTROL Medical Analysis Systems, Inc. JJY Class I 1996-04-03
K960378 ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS Actimed Laboratories, Inc. JJX Class I 1996-04-03
K960174 UNIMARK MIDSTREAM PREGNANCY TEST STICK Biotech Atlantic, Inc. LCX Class II 1996-04-01
K960088 TRUE TRIGLYCERIDE Diagnostic Chemicals , Ltd. CDT Class I 1996-04-01
K960115 HICHEM BUN/UREA REAGENT KIT Elan Pharma, Inc. CDQ Class II 1996-03-29
K960913 ACCESS FREE T3 ASSAY Bio-Rad Laboratories, Inc. CDP Class II 1996-03-29
K960274 ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY Orgentec JIR Class I 1996-03-29
K960250 VACUTAINER BRAND PLUS SERUM & SST TUBES Becton Dickinson Vacutainer Systems JKA Class II 1996-03-29
K960171 ACTIVE CROSSLAPS ELISA Diagnostic Systems Laboratories, Inc. JMM Class I 1996-03-28
K960054 900UDX URINE PATHOLOGY SYSTEM Intl. Remote Imaging Systems KQO Class I 1996-03-22
K953606 BEST PREGNANCY TEST Ameritek, Inc. LCX Class II 1996-03-22
K955629 LXN FRUCTOSAMINE TEST Lxn Corp. JJX Class I 1996-03-20
K936240 SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE) Sudormed, Inc. JKA Class II 1996-03-19
K960298 VIVASPIN 4 10,000 MW Vivascience, Inc. JJH Class I 1996-03-19
K960412 T-3 MICROWELL EIA MODEL 7013 Biomerica, Inc. CDP Class II 1996-03-19
K955353 ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT Tcpi, Inc. JHI Class II 1996-03-19
K960436 SELFCARE EARLY PREGNANCY TEST Selfcare, Inc. LCX Class II 1996-03-19
K960117 PLATFORM ONESTEP PREGNANCY HOME TEST Syntron Bioresearch, Inc. LCX Class II 1996-03-19
K955939 CALCIUM REAGENT Derma Media Lab., Inc. CIC Class II 1996-03-13
K955781 ALBUMIN Derma Media Lab., Inc. CIX Class II 1996-03-13
K960154 PSA CONTROLS Diagnostic Products Corp. JJX Class I 1996-03-13
K955940 TOTAL BILIRUBIN REAGENT Derma Media Lab., Inc. CIG Class II 1996-03-13
K955938 CREATININE REAGENT Derma Media Lab., Inc. CGX Class II 1996-03-12
K955936 TOTAL PROTEIN REAGENT Derma Media Lab., Inc. CEK Class II 1996-03-12
K955812 SYSCON TURMOR MARKER CONTROL Scantibodies Laboratory, Inc. JJY Class I 1996-03-12
K955937 INORGANIC PHOSPHORUS REAGENT Derma Media Lab., Inc. CEO Class I 1996-03-12
K960120 STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS Nova Biomedical Corp. JFP Class II 1996-03-11
K954977 URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) Teco Diagnostics JRE Class I 1996-03-11
K960085 ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS Alko Diagnostic Corp. JIX Class II 1996-03-11
K960793 SYNERMED ENZYMATIC CO2 REAGENT KIT Synermed, Inc. KHS Class II 1996-03-11
K955025 AXSYM PROGESTERONE Abbott Laboratories JLS Class I 1996-03-07
K944458 ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST Boehringer Mannheim Corp. CHH Class I 1996-03-06
K960550 ACTIVE T3 RIA Diagnostic Systems Laboratories, Inc. CDP Class II 1996-03-06
K960551 DSL ACTIVE HUMAN GROWTH HORMONE ELISA Diagnostic Systems Laboratories, Inc. CFL Class I 1996-03-06
K955903 SELFCARE EARLY PREGNANCY TEST Cambridge Diagnostics Ireland, Ltd. LCX Class II 1996-03-06
K955630 RNA MEDICAL HEMAT CONTROL Bionostics, Inc. JJR Class I 1996-03-01
K955796 IRON CALIBRATOR & CALIBRATION VERIFICATION SET Data Medical Associates, Inc. JJX Class I 1996-02-29
K955302 SERUM BICARBONATE/CARBON DIOXIDE Data Medical Associates, Inc. KHS Class II 1996-02-29
K955266 ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT Boehringer Mannheim Italia Spa JHI Class II 1996-02-29
K960060 DSL ACTIVE PROLACTIN IRMA Diagnostic Systems Laboratories, Inc. CFT Class I 1996-02-29
K954840 ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245 Sigma Diagnostics, Inc. CJE Class II 1996-02-28
K955496 URIC ACID CATALOGE# 220-93/94/97 Diagnostic Chemicals , Ltd. KNK Class I 1996-02-23
K955374 EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER Medica Corp. JGS Class II 1996-02-23
K955468 OPUS PROLACTIN CONTROLS Behring Diagnostics, Inc. JJX Class I 1996-02-23
K955114 DSL AACTIVE DHEA EIA KIT Diagnostic Systems Laboratories, Inc. JKC Class I 1996-02-23
K955375 EASYSTAT SODIUM/POTASSIUM ANALYZER Medica Corp. JGS Class II 1996-02-23
K951457 GLUCOCHEK POCKETLAB Clinical Diagnostics, Inc. CGA Class II 1996-02-22
K955858 N/T PROTEIN CONTROL SY/L, M AND H Behring Diagnostics, Inc. JJY Class I 1996-02-21
K955376 IMMULITE HGH Diagnostic Products Corp. CFL Class I 1996-02-16
K960066 IMMULITE ACTH Diagnostic Products Corp. CKG Class II 1996-02-16
K954833 ACCU-CHEK ADVANTAGE TEST STRIPS Boehringer Mannheim Corp. LFR Class II 1996-02-15
K951221 TOTAL CO2 Randox Laboratories, Ltd. KHS Class II 1996-02-15
K955868 BOEHRINGER MANNHEIM CARDIAC T TROPNIN T Boehringer Mannheim Corp. MMI Class II 1996-02-14
K954247 SYSCON CONTROL ASSAYED & UNASSAYED Scantibodies Laboratory, Inc. JJY Class I 1996-02-14
K955793 IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM Instrumentation Laboratory CO CHL Class II 1996-02-14
K953847 ROCHE REAGENT FOR GLUCOSE Roche Diagnostic Systems, Inc. CFR Class II 1996-02-13
K951848 AIA-PACK CPR ASSAY Tosoh Medics, Inc. JKD Class I 1996-02-13
K955139 OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT Olympus America, Inc. JMO Class I 1996-02-12
K955647 VIDAS ESTRADIOL II (E2II) ASSAY Biomerieux Vitek, Inc. CHP Class I 1996-02-06
K955870 IMMULITE TOTAL TESTOSTERONE Diagnostic Products Corp. CDZ Class I 1996-02-06
K955769 ACCESS PROGESTERONE ASSAY Bio-Rad Laboratories, Inc. JLS Class I 1996-02-05
K955264 NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2 Nova Biomedical Corp. JJY Class I 1996-02-02
K955252 NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4 Nova Biomedical Corp. JJY Class I 1996-02-02
K955260 NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION Nova Biomedical Corp. JJY Class I 1996-02-02
K950481 NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT Isolab, Inc. JIA Class I 1996-02-01
K955752 OLYMPUS URIC ACID REAGENT Olympus America, Inc. CDO Class I 1996-01-31
K955438 URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) Teco Diagnostics JIR Class I 1996-01-29
K943366 IL TEST ACID PHOSPHATASE Instrumentation Laboratory CO CKB Class II 1996-01-29
K955434 ACCESS FOLATE ASSAY (MODIFICATION) Beckman Coulter, Inc. CGN Class II 1996-01-29
K943547 PHENYLALANINE TEST KIT Isolab, Inc. JNB Class II 1996-01-26
K955284 OPUS TROPONIN I Behring Diagnostics, Inc. MMI Class II 1996-01-25
K954992 ROCHE COBAS INTEGRA REAGENT CASSETTES Roche Diagnostic Systems, Inc. CIT Class II 1996-01-25
K955435 ACCESS TOTAL T3 ASSAY (MODIFICATION) Bio-Rad Laboratories, Inc. CDP Class II 1996-01-24
K955436 ACCESS VITAMIN B12 ASSAY (MODIFICATION) Bio-Rad Laboratories, Inc. CDD Class II 1996-01-24
K954332 RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM Bayer Corp. CGN Class II 1996-01-24
K952557 TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS Sigma Diagnostics, Inc. CDP Class II 1996-01-24
K953077 PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM Beckman Instruments, Inc. CDF Class I 1996-01-05

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