meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
61
Latest Decision
1996-07-23

Clearances · page 47 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K962219 QUICKSTICK ONE STEP PREGNANCY TEST(9010) Phamatech LCX Class II 1996-07-23
K954326 STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY Solarcare Technologies Corp,Inc. JIT Class II 1996-07-23
K962694 OPUS B12 CONTROLS Behring Diagnostics, Inc. JJX Class I 1996-07-22
K961491 ELECSYS TSH ASSAY Boehringer Mannheim Corp. JLW Class II 1996-07-22
K962630 DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL Casco Standards JJY Class I 1996-07-22
K962573 ELECSYS PRECICONTROL TSH Boehringer Mannheim Corp. JJX Class I 1996-07-22
K954156 STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY Solarcare Technologies Corp,Inc. KQO Class I 1996-07-22
K962574 WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) Waters Corporation LEQ Class I 1996-07-22
K961750 DOCUMENT CARDIAC ASSAYED CONTROL Casco Standards JJY Class I 1996-07-22
K962575 ELECSYS PRECICONTROL CARDIAC Boehringer Mannheim Corp. JJY Class I 1996-07-22
K954685 URITEST - NITRITE IN URINE TEST Tcpi, Inc. JMT Class I 1996-07-22
K961179 SENTINEL LIPASE LIQUID MODEL 17.401B Equal Diagnostics, Inc. CHI Class I 1996-07-19
K960029 HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT Morax CEF Class I 1996-07-17
K962406 N CRP STANDARD SY Behring Diagnostics, Inc. JIX Class II 1996-07-16
K962410 N PROTEIN STANDARD PY Behring Diagnostics, Inc. JIX Class II 1996-07-16
K961650 NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT Nichols Institute Diagnostics JLW Class II 1996-07-16
K962355 FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) Bayer Corp. CDP Class II 1996-07-12
K962056 ADVANCED MICRO-OSMOMETER MODEL 3300 Advanced Instruments, Inc. JJM Class I 1996-07-11
K961562 OSTEOMARK Ostex Intl., Inc. JMM Class I 1996-07-11
K962183 BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES Armkel, LLC LCX Class II 1996-07-10
K954065 BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT Biochem Immunosystems (U.S.), Inc. JHI Class II 1996-07-10
K962211 UBI MAGIWEL THYROXINE (T4) QUANTITATIVE United Biotech, Inc. KLI Class II 1996-07-08
K961678 HUMAN GROWTH HORMONE IMMUNOASSAY KIT Nichols Institute Diagnostics CFL Class I 1996-07-08
K960392 CDM Bio-Rad LDM Class I 1996-07-08
K961557 ALLIANCE 2690 SEPARATIONS MODULE Waters Corporation LDM Class I 1996-07-05
K960888 CHEK-STIX U.T.I. SELF-TEST Bayer Corp. JMT Class I 1996-07-05
K962432 LIQUISPEX URINE (MICRO)ALBUMIN CONTROL Clinical Controls, Inc. JJX Class I 1996-07-05
K961274 OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc. JJE Class I 1996-07-05
K953672 FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS Polymer Technology Intl. JMT Class I 1996-07-01
K961919 DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE Data Medical Associates, Inc. JPZ Class I 1996-07-01
K915704 AMYLASE (KINETIC) REAGENT SET Tech Intl. Co. CJD Class II 1996-06-28
K960053 SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM Selfcare, Inc. CGA Class II 1996-06-28
K961335 GEM PREMIER PLUS MODEL 5500 Mallinckrodt Sensor Systems, Inc. CHL Class II 1996-06-28
K960034 LXN BLOOD GLUCOSE TEST SYSTEM Lxn Corp. CGA Class II 1996-06-28
K961911 DSL ACTIVE I-HCG ELISA Diagnostic Systems Laboratories, Inc. JHI Class II 1996-06-28
K921968 IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST Tech-Co, Inc. JHJ Class II 1996-06-28
K962235 VITROS SPECIALTY DILUENT Johnson & Johnson Clinical Diagnostics, Inc. JJE Class I 1996-06-26
K961657 CIBA CORNING 400 SYSTEM Ciba Corning Diagnostics Corp. CHL Class II 1996-06-25
K962021 CIBA CORNING 348 SYSTEM Ciba Corning Diagnostics Corp. CHL Class II 1996-06-24
K961965 SURE CHECK PREGNANCY TEST Chembio Diagnostic Systems, Inc. LCX Class II 1996-06-24
K955102 BIODATA TESTOSTERONE MAIA KIT Biochem Immunosystems (U.S.), Inc. CDZ Class I 1996-06-24
K961337 EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM Medisense, Inc. CGA Class II 1996-06-21
K961694 IMPACT Matrix Technologies Corp. JQW Class I 1996-06-21
K955489 CALIBRATION SERUM LEVEL 1 & 2 Randox Laboratories, Ltd. JIX Class II 1996-06-21
K954514 UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE Sciteck Diagnostics, Inc. KQO Class I 1996-06-21
K962126 ACS CKMB II IMMUNOASSAY Ciba Corning Diagnostics Corp. JHS Class II 1996-06-21
K961282 GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 Diagnostic Chemicals , Ltd. CFR Class II 1996-06-21
K953211 AMYLASE (ETHYLIDENE PNGPG7) KIT Randox Laboratories, Ltd. CIJ Class II 1996-06-21
K961326 EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER Medica Corp. CEM Class II 1996-06-21
K962041 ACS LH2 IMMUNOASSAY Ciba Corning Diagnostics Corp. CEP Class I 1996-06-21
K961375 DIA SCREEN 10 WAY REAGENT STRIPS Genesis Labs, Inc. JIL Class II 1996-06-18
K961412 CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO Bayer Corp. JHY Class II 1996-06-18
K961510 ACS FRT4 IMMUNOASSAY Ciba Corning Diagnostics Corp. JJX Class I 1996-06-17
K960874 COMPLEMENT CONTROL Wako Chemicals USA, Inc. JJX Class I 1996-06-14
K953661 FIRST CHOICE GLUCOSE URINE TEST STRIPS Polymer Technology Intl. JIL Class II 1996-06-14
K961355 MULTICHECK Radiometer America, Inc. JJS Class I 1996-06-14
K953662 FIRST CHOICE KETONES URINE TEST STRIPS Polymer Technology Intl. JIN Class I 1996-06-14
K961354 QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) Radiometer America, Inc. JJS Class I 1996-06-14
K961481 ELECSYS 2010 ANALYZER Boehringer Mannheim Corp. JJE Class I 1996-06-14
K933722 HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT Horizon Diagnostics, Inc. CDT Class I 1996-06-13
K961490 ELECSYS T4 ASSAY Boehringer Mannheim Corp. CDX Class II 1996-06-13
K961659 CEDIA CORE TDM MULTI-CAL Boehringer Mannheim Corp. JIX Class II 1996-06-13
K961487 ELECSYS HCG ASSAY Boehringer Mannheim Corp. DHA Class II 1996-06-12
K961458 AVL 9180 ELECTROLYTE ANALYZER Avl Scientific Corp. JFP Class II 1996-06-12
K960546 CLINITEK 50 URINE CHEMISTRY ANALYZER Bayer Corp. KQO Class I 1996-06-12
K961488 ELECSYS T-UPTAKE ASSAY Boehringer Mannheim Corp. KHQ Class II 1996-06-12
K961515 QUANTASE PHENYLALANINE ASSAY Shield Diagnostics, Ltd. JNB Class II 1996-06-12
K953680 FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS Polymer Technology Intl. JIN Class I 1996-06-12
K961828 LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) Bio-Rad JJT Class I 1996-06-11
K961501 ELECSYS CK-MB Boehringer Mannheim Corp. JHW Class II 1996-06-11
K961489 ELECSYS FT4 ASSAY Boehringer Mannheim Corp. CEC Class II 1996-06-11
K961500 ELECSYS TROPONIN T Boehringer Mannheim Corp. MMI Class II 1996-06-11
K961351 HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD Bayer Corp. DHA Class II 1996-06-03
K961431 LACTATE DEHYDROGENASE REAGENT SET Pointe Scientific, Inc., CFJ Class II 1996-06-03
K961712 TBD AT-HOME PREGNANCY TEST Armkel, LLC LCX Class II 1996-05-31
K961276 GASTRIN EIA MODEL 06B-555017 Biosyn , Ltd. CGC Class I 1996-05-30
K961236 UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE United Biotech, Inc. CDP Class II 1996-05-30
K955905 STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY Solarcare Technologies Corp,Inc. CEK Class II 1996-05-30
K955904 EKTACHEM DT LDL CHOLESTEROL KIT Johnson & Johnson Clinical Diagnostics, Inc. MRR Class I 1996-05-24
K955561 BUHLMANN VITAMIN B6 REA American Laboratory Products Co., Ltd. CDD Class II 1996-05-23
K961114 AST INCORPORATING DST Trace Scientific , Ltd. CIT Class II 1996-05-23
K955286 EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) Johnson & Johnson Clinical Diagnostics, Inc. CGA Class II 1996-05-17
K955356 ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL Diagnostic Systems Laboratories, Inc. CGI Class I 1996-05-15
K961196 EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) Johnson & Johnson Clinical Diagnostics, Inc. CDN Class II 1996-05-15
K961195 CHEM-CHEX STAT Streck Laboratories, Inc. JJY Class I 1996-05-15
K951877 AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE Chimera Research & Chemical, Inc. KQO Class I 1996-05-14
K960592 ELECTROLYTE STANDARDS Phoenix Diagnostics, Inc. JJR Class I 1996-05-13
K960648 PHEM-CHEK Femtek, Inc. LNW Class I 1996-05-13
K960485 SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS Beckman Instruments, Inc. JMO Class I 1996-05-10
K961099 EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+) Johnson & Johnson Clinical Diagnostics, Inc. JGS Class II 1996-05-07
K961226 EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE Johnson & Johnson Clinical Diagnostics, Inc. CJY Class II 1996-05-07
K960357 DSL ACTIVE I-HCG IRMA Diagnostic Systems Laboratories, Inc. JHI Class II 1996-05-07
K961115 EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) Johnson & Johnson Clinical Diagnostics, Inc. CEM Class II 1996-05-07
K961043 SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) Scantibodies Laboratory, Inc. JKR Class II 1996-05-06
K961293 QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2 Consolidated Technologies, Inc. JJY Class I 1996-05-02
K955707 ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT Excel Scientific, Inc. DHA Class II 1996-05-02
K960377 ENA-C-T TOTAL CHOLESTEROL TEST Actimed Laboratories, Inc. CHH Class I 1996-05-02
K953452 KETOREX C SANWA Ihara Medics U.S., Inc. JMK Class I 1996-05-02
K960733 MINISTICK PREGNANCY TEST Vanguard Biomedical Corp. LCX Class II 1996-05-01
K954158 STC DIAGNOSTICS AUTO-LYTE PH ASSAY Solarcare Technologies Corp,Inc. KQO Class I 1996-04-30

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