Atlas FDA

Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT (K961650)Nichols Institute Diagnostics1996-07-16
N PROTEIN STANDARD PY (K962410)Behring Diagnostics, Inc.1996-07-16
FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K962355)Bayer Corp.1996-07-12
OSTEOMARK (K961562)Ostex Intl., Inc.1996-07-11
ADVANCED MICRO-OSMOMETER MODEL 3300 (K962056)Advanced Instruments, Inc.1996-07-11
BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES (K962183)Armkel, LLC1996-07-10
BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT (K954065)Biochem Immunosystems (U.S.), Inc.1996-07-10
HUMAN GROWTH HORMONE IMMUNOASSAY KIT (K961678)Nichols Institute Diagnostics1996-07-08
UBI MAGIWEL THYROXINE (T4) QUANTITATIVE (K962211)United Biotech, Inc.1996-07-08
CDM (K960392)Bio-Rad1996-07-08
ALLIANCE 2690 SEPARATIONS MODULE (K961557)Waters Corporation1996-07-05
CHEK-STIX U.T.I. SELF-TEST (K960888)Bayer Corp.1996-07-05
LIQUISPEX URINE (MICRO)ALBUMIN CONTROL (K962432)Clinical Controls, Inc.1996-07-05
OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER (K961274)Olympus America, Inc.1996-07-05
FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS (K953672)Polymer Technology Intl.1996-07-01
DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE (K961919)Data Medical Associates, Inc.1996-07-01
IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST (K921968)Tech-Co, Inc.1996-06-28
GEM PREMIER PLUS MODEL 5500 (K961335)Mallinckrodt Sensor Systems, Inc.1996-06-28
AMYLASE (KINETIC) REAGENT SET (K915704)Tech Intl. Co.1996-06-28
DSL ACTIVE I-HCG ELISA (K961911)Diagnostic Systems Laboratories, Inc.1996-06-28
SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM (K960053)Selfcare, Inc.1996-06-28
LXN BLOOD GLUCOSE TEST SYSTEM (K960034)Lxn Corp.1996-06-28
VITROS SPECIALTY DILUENT (K962235)Johnson & Johnson Clinical Diagnostics, Inc.1996-06-26
CIBA CORNING 400 SYSTEM (K961657)Ciba Corning Diagnostics Corp.1996-06-25
SURE CHECK PREGNANCY TEST (K961965)Chembio Diagnostic Systems, Inc.1996-06-24
CIBA CORNING 348 SYSTEM (K962021)Ciba Corning Diagnostics Corp.1996-06-24
BIODATA TESTOSTERONE MAIA KIT (K955102)Biochem Immunosystems (U.S.), Inc.1996-06-24
EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER (K961326)Medica Corp.1996-06-21
CALIBRATION SERUM LEVEL 1 & 2 (K955489)Randox Laboratories, Ltd.1996-06-21
GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 (K961282)Diagnostic Chemicals , Ltd.1996-06-21
ACS CKMB II IMMUNOASSAY (K962126)Ciba Corning Diagnostics Corp.1996-06-21
UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE (K954514)Sciteck Diagnostics, Inc.1996-06-21
ACS LH2 IMMUNOASSAY (K962041)Ciba Corning Diagnostics Corp.1996-06-21
IMPACT (K961694)Matrix Technologies Corp.1996-06-21
EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM (K961337)Medisense, Inc.1996-06-21
AMYLASE (ETHYLIDENE PNGPG7) KIT (K953211)Randox Laboratories, Ltd.1996-06-21
DIA SCREEN 10 WAY REAGENT STRIPS (K961375)Genesis Labs, Inc.1996-06-18
CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO (K961412)Bayer Corp.1996-06-18
ACS FRT4 IMMUNOASSAY (K961510)Ciba Corning Diagnostics Corp.1996-06-17
COMPLEMENT CONTROL (K960874)Wako Chemicals USA, Inc.1996-06-14
ELECSYS 2010 ANALYZER (K961481)Boehringer Mannheim Corp.1996-06-14
FIRST CHOICE GLUCOSE URINE TEST STRIPS (K953661)Polymer Technology Intl.1996-06-14
QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) (K961354)Radiometer America, Inc.1996-06-14
FIRST CHOICE KETONES URINE TEST STRIPS (K953662)Polymer Technology Intl.1996-06-14
MULTICHECK (K961355)Radiometer America, Inc.1996-06-14
HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT (K933722)Horizon Diagnostics, Inc.1996-06-13
ELECSYS T4 ASSAY (K961490)Boehringer Mannheim Corp.1996-06-13
CEDIA CORE TDM MULTI-CAL (K961659)Boehringer Mannheim Corp.1996-06-13
FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS (K953680)Polymer Technology Intl.1996-06-12
ELECSYS T-UPTAKE ASSAY (K961488)Boehringer Mannheim Corp.1996-06-12
QUANTASE PHENYLALANINE ASSAY (K961515)Shield Diagnostics, Ltd.1996-06-12
AVL 9180 ELECTROLYTE ANALYZER (K961458)Avl Scientific Corp.1996-06-12
CLINITEK 50 URINE CHEMISTRY ANALYZER (K960546)Bayer Corp.1996-06-12
ELECSYS HCG ASSAY (K961487)Boehringer Mannheim Corp.1996-06-12
LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) (K961828)Bio-Rad1996-06-11
ELECSYS CK-MB (K961501)Boehringer Mannheim Corp.1996-06-11
ELECSYS TROPONIN T (K961500)Boehringer Mannheim Corp.1996-06-11
ELECSYS FT4 ASSAY (K961489)Boehringer Mannheim Corp.1996-06-11
HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD (K961351)Bayer Corp.1996-06-03
LACTATE DEHYDROGENASE REAGENT SET (K961431)Pointe Scientific, Inc.,1996-06-03
TBD AT-HOME PREGNANCY TEST (K961712)Armkel, LLC1996-05-31
GASTRIN EIA MODEL 06B-555017 (K961276)Biosyn , Ltd.1996-05-30
UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE (K961236)United Biotech, Inc.1996-05-30
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY (K955905)Solarcare Technologies Corp,Inc.1996-05-30
EKTACHEM DT LDL CHOLESTEROL KIT (K955904)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-24
BUHLMANN VITAMIN B6 REA (K955561)American Laboratory Products Co., Ltd.1996-05-23
AST INCORPORATING DST (K961114)Trace Scientific , Ltd.1996-05-23
EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) (K955286)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-17
ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL (K955356)Diagnostic Systems Laboratories, Inc.1996-05-15
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) (K961196)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-15
CHEM-CHEX STAT (K961195)Streck Laboratories, Inc.1996-05-15
AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE (K951877)Chimera Research & Chemical, Inc.1996-05-14
PHEM-CHEK (K960648)Femtek, Inc.1996-05-13
ELECTROLYTE STANDARDS (K960592)Phoenix Diagnostics, Inc.1996-05-13
SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS (K960485)Beckman Instruments, Inc.1996-05-10
EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+) (K961099)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-07
DSL ACTIVE I-HCG IRMA (K960357)Diagnostic Systems Laboratories, Inc.1996-05-07
EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE (K961226)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-07
EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) (K961115)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-07
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) (K961043)Scantibodies Laboratory, Inc.1996-05-06
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2 (K961293)Consolidated Technologies, Inc.1996-05-02
ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT (K955707)Excel Scientific, Inc.1996-05-02
ENA-C-T TOTAL CHOLESTEROL TEST (K960377)Actimed Laboratories, Inc.1996-05-02
KETOREX C SANWA (K953452)Ihara Medics U.S., Inc.1996-05-02
MINISTICK PREGNANCY TEST (K960733)Vanguard Biomedical Corp.1996-05-01
STC DIAGNOSTICS AUTO-LYTE PH ASSAY (K954158)Solarcare Technologies Corp,Inc.1996-04-30
TONOMETERED SLAINE BLOOD GAS CONTROL (K961441)Instrumentarium Corp.1996-04-30
CLEARBLUE EASY (K960316)Unipath , Ltd.1996-04-29
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 (K960561)Diagnostic Systems Laboratories, Inc.1996-04-26
AVL OPTI 1 PH/BLOOD GAS ANALYZER (K961161)Avl Scientific Corp.1996-04-26
DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS (K960103)Dade Intl., Inc.1996-04-26
BIONIKE A/Q PREGNANCY TEST (K960992)Bionike Laboratories, Inc.1996-04-25
OPUS CK-MB & TOTAL CK CONTROLS (K960275)Behring Diagnostics, Inc.1996-04-25
ALT INCORPORATING DST (K961123)Trace Scientific , Ltd.1996-04-25
SERUM VOLATILES CONTROL LEVEL 1 & 2 (K955691)Clinical Controls, Inc.1996-04-24
AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 (K955690)Clinical Controls, Inc.1996-04-24
TOTAL PROTEIN (URINE) (K951222)Randox Laboratories, Ltd.1996-04-24
MINICLINIC OVULATION PREDICTOR (K960233)Vanguard Biomedical Corp.1996-04-23
IMMUNOLOGY CONTROL (K960824)Medical Analysis Systems, Inc.1996-04-23
LIQUID CARDIAC MARKER 1,2,3 ASSAYED (K960246)Ciba Corning Diagnostics Corp.1996-04-23
← Previous Next →

Track Clinical Chemistry automatically

Every clearance here is in the API, with alerts when new ones post.