Atlas FDA

Clinical Chemistry

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

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RecordFirmDate
CREATININE STANDARD SOLUTION CALIBRATOR (K871756)Wako Chemicals USA, Inc.1987-05-27
TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS (K870998)Technicon Instruments Corp.1987-05-26
ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) (K871782)Biochemical Trade, Inc.1987-05-26
NEFA STANDARD SOLUTION CALIBRATOR (K871763)Wako Chemicals USA, Inc.1987-05-26
BIOMEK 1000C AUTOMATED LABORATORY WORK STATION (K871838)Beckman Instruments, Inc.1987-05-26
UREA N STANDARD SOLUTION CALIBRATOR (K871767)Wako Chemicals USA, Inc.1987-05-26
MAGNESIUM STANDARD SOLUTION CALIBRATOR (K871762)Wako Chemicals USA, Inc.1987-05-26
ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8 (K871150)Beckman Instruments, Inc.1987-05-26
URIC ACID STANDARD SOLUTION CALIBRATOR (K871768)Wako Chemicals USA, Inc.1987-05-26
CIBA CORNING MAGIC LITE ANALYZER II (K871874)Ciba Corning Diagnostics Corp.1987-05-26
GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA (K864282)Medical Device Consultants, Inc.1987-05-26
MICROMEDIC NEONATAL T4 KIT (K871008)Micromedic Systems1987-05-26
SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) (K871811)Boehringer Mannheim Corp.1987-05-26
GLUCOSE STANDARD SOLUTION CALIBRATOR (K871758)Wako Chemicals USA, Inc.1987-05-26
TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR (K871766)Wako Chemicals USA, Inc.1987-05-26
INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR (K871764)Wako Chemicals USA, Inc.1987-05-26
PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR (K871765)Wako Chemicals USA, Inc.1987-05-26
AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT (K871505)Micromedic Systems1987-05-26
CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY (K870987)Ciba Corning Diagnostics Corp.1987-05-26
MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT (K870904)Micromedic Systems1987-05-26
SYVA Q-SPEC PHOTOMETER (K871307)Syva Co.1987-05-26
QM2/QM300 CONTROL A PACK (K871342)Kallestad Diag, A Div. of Erbamont, Inc.1987-05-21
QM300 CALIBRATOR A PACK (K871341)Kallestad Diag, A Div. of Erbamont, Inc.1987-05-21
SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST (K870751)Syntron Bioresearch, Inc.1987-05-20
TYTEM(R) REAGENT DISPENSER (K871687)Medical Laboratory Automation Systems, Inc.1987-05-20
ABBOTT TESTPACK HCG COMBO (K870739)Abbott Laboratories1987-05-20
FOLLICLE STIMULATING HORMONE (HFSH) (K871317)Immuchem Corp.1987-05-20
REAGENTS 1263,1273,1284,1425,014301,053583 (K871531)American Research Products Co.1987-05-18
ENZYMATIC CHOLESTEROL REAGENT SET (K871676)Michclone Associates, Inc.1987-05-18
KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM (K871339)Kallestad Diag, A Div. of Erbamont, Inc.1987-05-15
CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY (K870965)Ciba Corning Diagnostics Corp.1987-05-14
VISION (TM) HDL CHOLESTEROL (K871461)Abbott Laboratories1987-05-14
TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583 (K871530)American Research Products Co.1987-05-14
HPROLACTIN KIT (K871542)Immuchem Corp.1987-05-14
ABBOTT A-GENT LD-1 ISOZYME REAGENT (K871240)Abbott Laboratories1987-05-13
CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS (K871677)Catachem, Inc.1987-05-12
AVL MODEL 985 ELECTROLYTE ANALYZER (K870657)Avl Scientific Corp.1987-05-12
KODAK EKTACHEM DT SLIDES (CA) (K870035)Eastman Kodak Company1987-05-12
DELFIA (TM) HTSH KIT (K871644)Lkb Instruments, Inc.1987-05-12
COLORIMETRIC BUN REAGENT KIT (K871651)Biochemical Trade, Inc.1987-05-12
IONOMETER EF AND ACCESSORIES (K870183)Smash Ent., Inc.1987-05-12
GLUCOSE ENZYME - COLOR REAGENT SET (K871650)Biochemical Trade, Inc.1987-05-12
EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 (K871638)Em Diagnostic Systems, Inc.1987-05-12
ACU-PREG-AL SLIDE TEST (K871294)Papibris Scientific, Inc.1987-05-12
RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL (K871508)Trace Scientific , Ltd.1987-05-08
IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR (K871664)Instrumentation Laboratory CO1987-05-08
(FPIA) ASSAY BUFFER (K871486)Windsor Laboratories, Inc.1987-05-08
RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) (K871509)Trace Scientific , Ltd.1987-05-08
CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II (K871537)Canyon Diagnostics, Inc.1987-05-06
ULTRA-VIOLET GLUCOSE REAGENT KIT (K871456)Biochemical Trade, Inc.1987-04-29
TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091 (K870958)Helena Laboratories1987-04-29
CALCIUM TEST (K870629)Sclavo, Inc.1987-04-29
EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 (K871414)Em Diagnostic Systems, Inc.1987-04-23
T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT (K870573)Cambridge Medical Technology1987-04-22
BIOMEK 1000 AUTOMATED LABORATORY WORK STATION (K870544)Beckman Instruments, Inc.1987-04-22
FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 (K871320)American Research Products Co.1987-04-22
MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000) (K871415)Dynatech Laboratories, Inc.1987-04-22
ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD (K871301)American Monitor Corp.1987-04-22
COLORIMETRIC URIC ACID REAGENT SET (K871417)Biochemical Trade, Inc.1987-04-22
CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS (K870928)Electro-Nucleonics Laboratories, Inc.1987-04-22
FLOW-PAC INORGANIC PHOSPHORUS REAGENTS (K871321)American Research Products Co.1987-04-22
WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM (K870949)Millipore Corp.1987-04-22
TITAN GEL MULTI-SLOT LIPO-17 SYSTEM (K871319)Helena Laboratories1987-04-22
CHLORIDE TEST (K870630)Sclavo, Inc.1987-04-22
SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (K870752)Miles Laboratories, Inc.1987-04-14
CHOLESTEROL DETERMINATION (K871260)Biochemical Trade, Inc.1987-04-13
U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL (K870737)U. S. Diagnostics, Inc.1987-04-13
NEUROCHEMICAL ANALYZER (K864729)Esa, Inc.1987-04-13
LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT (K870986)Beckman Instruments, Inc.1987-04-13
RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C) (K871269)Technicon Instruments Corp.1987-04-13
U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL (K870738)U. S. Diagnostics, Inc.1987-04-13
PROGESTERONE CLASP RADIOIMMUNOASSAY KIT (K871211)Biotecx Laboratories, Inc.1987-04-13
TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY (K870521)Hybritech, Inc.1987-04-08
FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339 (K871284)American Research Products Co.1987-04-08
MODIFICATION OF ACCU-CHEK II (K863481)Boehringer Mannheim Corp.1987-04-07
TRIGLYCERIDES DETERMINATION (K871122)Biochemical Trade, Inc.1987-04-07
LIQUID CHEMISTRY CONTROL, LEVEL I (K870684)U. S. Diagnostics, Inc.1987-04-06
SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) (K871058)Fisher Scientific Co., LLC1987-04-06
LIQUID CHEMISTRY CONTROL, LEVEL II (K870683)U. S. Diagnostics, Inc.1987-04-06
ATAC 1500 CHEMISTRY ANALYZER (K870836)Turpen Laboratory Systems, Inc.1987-04-01
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD (K870672)E.I. Dupont DE Nemours & Co., Inc.1987-04-01
CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY (K870833)Ciba Corning Diagnostics Corp.1987-04-01
AUTOPAK TSH MONOCLONAL IRMA KIT (K870245)Micromedic Systems1987-04-01
IQ TSH IMMUNOASSAY (K870244)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-04-01
ABBOTT SPECTRUM AMMONIA REAGENT (K870787)Abbott Laboratories1987-03-31
BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS (K870115)Berthold Analytical Instruments, Inc.1987-03-31
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B (K870564)Atlantic Antibodies1987-03-24
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL (K870862)Atlantic Antibodies1987-03-24
CENTRIPREP CONCENTRATOR (K870690)Amicon, Inc.1987-03-19
STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. (K870158)American Dade1987-03-19
ALANINE TRANSAMINASE (ALT) TEST KIT (K870879)Genetic Systems Corp.1987-03-19
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR (K870673)E.I. Dupont DE Nemours & Co., Inc.1987-03-19
EASY-TEST URIC ACID (URIC) #16606 (K870868)Em Diagnostic Systems, Inc.1987-03-19
DACOMED PENILE PROSTHESIS SIZER (K870320)Dacomed Corp.1987-03-17
STAVIP 3000 (K864436)Roseburg SA1987-03-16
RESUBMISSION OF THE KLEERZIT REAGENT (K864866)Advanced Biomedical Methods, Inc.1987-03-16
IQ FTI IMMUNOASSAY (K865104)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-16
MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER (K864872)Medica Corp.1987-03-13
SYVA ETS SYSTEM (K863245)Syva Co.1987-03-13
AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS (K870025)American Research Products Co.1987-03-13
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