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Panels › Clinical Chemistry › Product code CIG · Class 2

Diazo Colorimetry, Bilirubin

Regulation 862.1110

1510(k)s in 12 months (235 all time)
0recalls in 12 months (19 all time)
19recalls that name a 510(k)
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Top companies in CIG

Company510(k)sRecalls
Em Diagnostic Systems, Inc.210
Abbott Laboratories151
Data Medical Associates, Inc.100
Diagnostic Chemicals , Ltd.80
Siemens Healthcare Diagnostics, Inc.35
Ortho-Clinical Diagnostics, Inc.16
Synermed, Inc.70
Harleco60
Pointe Scientific, Inc.,42
Roche Diagnostics41
Decided510(k)Device and applicantCode
Apr 1, 1982K820714DOW BILIRUBIN(DIRECT) DETERMINATION
The Dow Chemical Co.
CIG
Apr 1, 1982K820675BILIRUBIN(TOTAL) DETERMINATION CTMS
The Dow Chemical Co.
CIG
Nov 27, 1981K812841TOTAL & DIRECT BILIRUBIN REAGENT SET
Anco Medical Reagents & Assoc.
CIG
Oct 20, 1981K812784BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD
Beckman Instruments, Inc.
CIG
Oct 19, 1981K812754BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN
Beckman Instruments, Inc.
CIG
Jul 23, 1981K811881KING DIAGNOSTICS TOTAL BILIRUBIN TEST
King Diagnostics, Inc.
CIG
Feb 2, 1981K810055STANBIO BILIRUBIN TEST SET
Stanbio Laboratory
CIG
Nov 26, 1980K802630CAFFEINE REAGENT DIAZO COLORIMETRY
American Monitor Corp.
CIG
Oct 10, 1980K802154REAGENTS USED-QUAN. MEASURE OF SERUM
Panmed, Inc.
CIG
Jun 9, 1980K801117COBAS TOTAL BILIRUBIN REAGENT & DILUENT
Roche Analytical Instruments, Inc.
CIG
May 28, 1980K800686REAGENT FOR DETERM. DIRECT BILIRUBIN
Diagnostic Solutions, Inc.
CIG
May 28, 1980K800675REAGENTS FOR DETERM. TOTAL BILIRUBIN
Diagnostic Solutions, Inc.
CIG
Dec 18, 1979K792465CONNECTICUT DIAGNOSTICS, LTS. DIRECT
Connecticut Diagnostics, Ltd.
CIG
Dec 7, 1979K792415ELVI TOTAL BILIRUBIN & FRACTIONS
Volu Sol Medical Industries
CIG
Dec 6, 1979K792411ELVI TOTAL BILIRUBIN & FRACTIONS
Volu Sol Medical Industries
CIG
Dec 6, 1979K792338DONNECT. DIAG. TOTAL BILIRUBIN REAGENTS
Connecticut Diagnostics, Ltd.
CIG
Jun 15, 1979K790608BL BILIRUBINOMETER
Advanced Instruments, Inc.
CIG
May 15, 1979K790578GAMMA SMAC REAGENTS
Gamma Enterprises, Inc.
CIG
Jan 3, 1979K781921BILIRUBIN, DINGLE VALVE DPD
Boehringer Mannheim Corp.
CIG
Oct 24, 1978K781610BILIRUBIN DETERMINTAITON IN SERUM
Fisher Scientific Co., LLC
CIG
May 26, 1978K780826BILIRUBIN RAPID STAT KIT
Pierce Chemical Co.
CIG
May 19, 1978K780524ULTRACHEM T-BILI 64971 GILFORD 3500
Harleco
CIG
Oct 19, 1977K771840TOTAL BILIRUBIN
Gamma Enterprises, Inc.
CIG
Sep 13, 1977K771621MULTISTAT III, TOTAL BILIRUBIN TEST
Instrumentation Laboratory CO
CIG
Jul 21, 1977K771092UNIPAK TOTAL & DIRECT BILIRUBIN
Harleco
CIG
Jul 21, 1977K771089UNIPAK TOTAL BILIRUBIN
Harleco
CIG
May 10, 1977K770458BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR.
Icn Pharmaceuticals, Inc.
CIG
Jan 31, 1977K770121MANUEL BILIRUBIN REAGENT SET
Harleco
CIG
Dec 21, 1976K761218AUTO TOTAL BILIRUBIN REAGENT
Harleco
CIG
Nov 30, 1976K761027AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN
Harleco
CIG
Nov 2, 1976K760409SODIUM NITRITE
J.T. Baker Chemical Co.
CIG
Nov 2, 1976K760408POTASSIUM SODIUM TARTRATE
J.T. Baker Chemical Co.
CIG
Oct 29, 1976K760479REAGENT, TOTAL BILIRUBIN DETERMINATION
Simmler & Son, Inc.
CIG
Oct 29, 1976K760407SULFANILIC ACID
J.T. Baker Chemical Co.
CIG
Oct 29, 1976K760406CAFFEINE DILUENT
J.T. Baker Chemical Co.
CIG

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