Atlas FDA

CIG

235 FDA 510(k) clearances · Product code

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RecordFirmDate
BILIRUBIN(TOTAL) DETERMINATION CTMS (K820675)The Dow Chemical Co.1982-04-01
DOW BILIRUBIN(DIRECT) DETERMINATION (K820714)The Dow Chemical Co.1982-04-01
TOTAL & DIRECT BILIRUBIN REAGENT SET (K812841)Anco Medical Reagents & Assoc.1981-11-27
BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD (K812784)Beckman Instruments, Inc.1981-10-20
BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN (K812754)Beckman Instruments, Inc.1981-10-19
KING DIAGNOSTICS TOTAL BILIRUBIN TEST (K811881)King Diagnostics, Inc.1981-07-23
STANBIO BILIRUBIN TEST SET (K810055)Stanbio Laboratory1981-02-02
CAFFEINE REAGENT DIAZO COLORIMETRY (K802630)American Monitor Corp.1980-11-26
REAGENTS USED-QUAN. MEASURE OF SERUM (K802154)Panmed, Inc.1980-10-10
COBAS TOTAL BILIRUBIN REAGENT & DILUENT (K801117)Roche Analytical Instruments, Inc.1980-06-09
REAGENTS FOR DETERM. TOTAL BILIRUBIN (K800675)Diagnostic Solutions, Inc.1980-05-28
REAGENT FOR DETERM. DIRECT BILIRUBIN (K800686)Diagnostic Solutions, Inc.1980-05-28
CONNECTICUT DIAGNOSTICS, LTS. DIRECT (K792465)Connecticut Diagnostics, Ltd.1979-12-18
ELVI TOTAL BILIRUBIN & FRACTIONS (K792415)Volu Sol Medical Industries1979-12-07
ELVI TOTAL BILIRUBIN & FRACTIONS (K792411)Volu Sol Medical Industries1979-12-06
DONNECT. DIAG. TOTAL BILIRUBIN REAGENTS (K792338)Connecticut Diagnostics, Ltd.1979-12-06
BL BILIRUBINOMETER (K790608)Advanced Instruments, Inc.1979-06-15
GAMMA SMAC REAGENTS (K790578)Gamma Enterprises, Inc.1979-05-15
BILIRUBIN, DINGLE VALVE DPD (K781921)Boehringer Mannheim Corp.1979-01-03
BILIRUBIN DETERMINTAITON IN SERUM (K781610)Fisher Scientific Co., LLC1978-10-24
BILIRUBIN RAPID STAT KIT (K780826)Pierce Chemical Co.1978-05-26
ULTRACHEM T-BILI 64971 GILFORD 3500 (K780524)Harleco1978-05-19
TOTAL BILIRUBIN (K771840)Gamma Enterprises, Inc.1977-10-19
MULTISTAT III, TOTAL BILIRUBIN TEST (K771621)Instrumentation Laboratory CO1977-09-13
UNIPAK TOTAL & DIRECT BILIRUBIN (K771092)Harleco1977-07-21
UNIPAK TOTAL BILIRUBIN (K771089)Harleco1977-07-21
BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. (K770458)Icn Pharmaceuticals, Inc.1977-05-10
MANUEL BILIRUBIN REAGENT SET (K770121)Harleco1977-01-31
AUTO TOTAL BILIRUBIN REAGENT (K761218)Harleco1976-12-21
AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN (K761027)Harleco1976-11-30
POTASSIUM SODIUM TARTRATE (K760408)J.T. Baker Chemical Co.1976-11-02
SODIUM NITRITE (K760409)J.T. Baker Chemical Co.1976-11-02
REAGENT, TOTAL BILIRUBIN DETERMINATION (K760479)Simmler & Son, Inc.1976-10-29
SULFANILIC ACID (K760407)J.T. Baker Chemical Co.1976-10-29
CAFFEINE DILUENT (K760406)J.T. Baker Chemical Co.1976-10-29
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