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)
Top companies in CIG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 1986 | K863055 | BILIFAST J. D. Assoc. | CIG |
| Aug 19, 1986 | K862359 | METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM E.I. Dupont DE Nemours & Co., Inc. | CIG |
| Jul 1, 1986 | K862299 | AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS Amresco, Inc. | CIG |
| Jun 27, 1986 | K861998 | TOTAL BILIRUBIN TEST KIT Ciba Corning Diagnostics Corp. | CIG |
| Jun 25, 1986 | K861671 | DIRECT BILIRUBIN PROCEDURE Data Medical Associates, Inc. | CIG |
| May 29, 1986 | K861651 | TOTAL BILIRUBIN PROCEDURE Data Medical Associates, Inc. | CIG |
| Apr 24, 1986 | K861413 | BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. | CIG |
| Apr 21, 1986 | K861095 | BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04 Diagnostic Chemicals, Ltd. (Usa), CA | CIG |
| Apr 21, 1986 | K861094 | BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02 Diagnostic Chemicals, Ltd. (Usa), CA | CIG |
| Apr 3, 1986 | K860424 | A-GENT LIQUID TOTAL BILIRUBIN Abbott Laboratories | CIG |
| Mar 17, 1986 | K860214 | TOTAL BILIRUBIN REAGENT SET Sterling Diagnostics, Inc. | CIG |
| Mar 5, 1986 | K855079 | NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95 Em Diagnostic Systems, Inc. | CIG |
| Feb 21, 1986 | K860257 | DIRECT BILIRUBIN Pointe Scientific, Inc., | CIG |
| Jan 14, 1986 | K855195 | DIRECT & TOTAL BILIRUBIN SET Technostics Intl. | CIG |
| Nov 25, 1985 | K854180 | IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN Clinical Data, Inc. | CIG |
| May 30, 1985 | K852008 | T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL Alpkem Corp. | CIG |
| Apr 3, 1985 | K850748 | I-L TEST, DIRECT BILIRUBIN SET Allied Instrumentation Laboratory | CIG |
| Apr 3, 1985 | K843908 | ABBOTT TDT EIA Abbott Laboratories | CIG |
| Apr 1, 1985 | K850901 | DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE Data Medical Associates, Inc. | CIG |
| Mar 1, 1985 | K850379 | DIRECT BILIRUBIN FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CIG |
| Sep 20, 1984 | K843329 | SYSTEMATE D-BILI 67213 Em Diagnostic Systems, Inc. | CIG |
| Sep 20, 1984 | K843328 | SYSTEMATE T-BILI 67212 Em Diagnostic Systems, Inc. | CIG |
| Sep 7, 1984 | K843178 | TOTAL BILIRUBIN TEST Sclavo, Inc. | CIG |
| Sep 4, 1984 | K843032 | BILIRUBIN ASSAY KIT - TOTAL Diagnostic Chemicals, Ltd. (Usa) | CIG |
| Sep 4, 1984 | K843027 | BILIRUBIN ASSAY KIT DIRECT Diagnostic Chemicals, Ltd. (Usa) | CIG |
| Aug 17, 1984 | K842809 | TECHNICON RA-1000 SYS, DIRECT BILIRUBIN Technicon Instruments Corp. | CIG |
| Aug 17, 1984 | K842385 | ACA CONJUGATED BILIRUBIN ANALYTICAL E.I. Dupont DE Nemours & Co., Inc. | CIG |
| Jun 7, 1984 | K841892 | RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT Reagents Applications, Inc. | CIG |
| May 30, 1984 | K840757 | ELVI 444 BILITRON Logos Scientific, Inc. | CIG |
| May 16, 1984 | K841572 | DIRECT BILIRUBIN REAGENT Hi Chem, Inc. | CIG |
| May 1, 1984 | K841050 | TOTAL BILIRUBIN REAGENT SET Medical Specialties, Inc. | CIG |
| Apr 25, 1984 | K840486 | TOTAL BILIRUBIN REAGENT Somas Medical Industries, Inc. | CIG |
| Apr 18, 1984 | K840880 | EKTACHEM CLINICAL CHEM. SLIDES Eastman Kodak Company | CIG |
| Apr 13, 1984 | K840779 | NEONATAL BILIRUBIN REAGENT American Dade | CIG |
| Apr 5, 1984 | K840777 | DIRECT BILIRUBIN REAGENT American Dade | CIG |
| Apr 4, 1984 | K840606 | EKTACHEM CLINICAL CHEM. SLIDES Eastman Kodak Company | CIG |
| Mar 19, 1984 | K840111 | TOTAL BILIRUBIN Fisher Scientific Co., LLC | CIG |
| Mar 9, 1984 | K840564 | LIQUI ZYME TOTAL BILIRUBIN REAGENT American Research Products Co. | CIG |
| Nov 7, 1983 | K832942 | TOTAL & DIRECT BILIRUBIN PROCEDURES Sandare Chemical Co., Inc. | CIG |
| Oct 14, 1983 | K833004 | PARAMAX TOTAL BILIRUBIN REAGENT American Dade | CIG |
| Oct 14, 1983 | K832748 | COMPUR* EASYTOUCH TOTAL BILIRUBIN Worthington Diagnostic Systems | CIG |
| Sep 26, 1983 | K832870 | DIAZO COLORIMETRY, BILLIRUBIN Pointe Scientific, Inc., | CIG |
| Sep 1, 1983 | K832357 | ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK E.I. Dupont DE Nemours & Co., Inc. | CIG |
| Aug 31, 1983 | K832236 | SIGMA PROCEDURE #550 DETERM. BILIRUB Sigma Chemical Co. | CIG |
| Jul 18, 1983 | K831844 | DIRECT BILIRUBIN REAGENT Gilford Diagnostics | CIG |
| Jul 18, 1983 | K831843 | GILCHEM TOTAL BILIRUBIN REAGENT Gilford Diagnostics | CIG |
| Apr 6, 1983 | K830714 | TOTAL BILIRUBIN REAGENT Hi Chem, Inc. | CIG |
| Jul 14, 1982 | K821873 | ULTRACHEM T-BILI Harleco Diagnostics | CIG |
| Jul 13, 1982 | K821197 | TOTAL BILIRUBIN REAGENT SET Omega Medical Electronics | CIG |
| Jun 1, 1982 | K821462 | ULTRACHEM T-BILI, #64971 Emd Chemicals, Inc. | CIG |
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