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 |
|---|---|---|---|
| May 10, 1990 | K897174 | OLYMPUS(TM) TOTAL BILIRUBIN Em Diagnostic Systems, Inc. | CIG |
| Apr 25, 1990 | K901266 | COULTER TOTAL BILIRUBIN REAGENT Coulter Corp. | CIG |
| Apr 16, 1990 | K900571 | AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) American Research Products Co. | CIG |
| Mar 19, 1990 | K897176 | SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX Em Diagnostic Systems, Inc. | CIG |
| Mar 15, 1990 | K897175 | OLYMPUS DIRECT BILIRUBIN Em Diagnostic Systems, Inc. | CIG |
| Feb 27, 1990 | K900259 | DIRECT BILIRUBIN REAGENT Medical Analysis Systems, Inc. | CIG |
| Feb 27, 1990 | K896232 | COBAS READY TOTAL BILIRUBIN REAGENT Roche Diagnostic Systems, Inc. | CIG |
| Nov 14, 1989 | K895822 | TOTAL BILIRUBIN L.F. Sclavo, Inc. | CIG |
| Oct 17, 1989 | K895119 | SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406 Em Diagnostic Systems, Inc. | CIG |
| Oct 17, 1989 | K895118 | SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407 Em Diagnostic Systems, Inc. | CIG |
| Aug 15, 1989 | K892801 | CLINISTAT TOTAL BILIRUBIN REAGENT TEST Heraeus Kulzer, Inc. | CIG |
| Aug 11, 1989 | K893730 | DIRECT BILIRUBIN REAGENT Medical Analysis Systems, Inc. | CIG |
| Jul 20, 1989 | K892668 | TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS Catachem, Inc. | CIG |
| Jun 19, 1989 | K892905 | DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI. Catachem, Inc. | CIG |
| May 10, 1989 | K891240 | DIRECT BILIRUBIN FOR CONTINUOUS FLOW Catachem, Inc. | CIG |
| Apr 4, 1989 | K891025 | TOTAL BILIRUBIN FOR CONTINUOUS FLOW Catachem, Inc. | CIG |
| Mar 6, 1989 | K890070 | TOTAL BILIRUBIN REAGENT, CONCENTRATED Trace Scientific , Ltd., AU | CIG |
| Jan 30, 1989 | K885285 | DIRECT BILIRUBIN TEST CATALOG NO. SR1008 Em Diagnostic Systems, Inc. | CIG |
| Jan 30, 1989 | K885284 | TOTAL BILIRUBIN TEST CATALOG NO. SR1007 Em Diagnostic Systems, Inc. | CIG |
| Jan 27, 1989 | K871115 | UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON. Labo Science-USA, Inc. | CIG |
| Dec 15, 1988 | K884224 | TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS A-Kem, Inc. | CIG |
| Aug 3, 1988 | K880437 | VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM Abbott Laboratories | CIG |
| Aug 2, 1988 | K882459 | DIAZO, COLORIMETRIC BILIRUBIN Tech-Neal Scientific, Inc. | CIG |
| Jun 7, 1988 | K881798 | TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN Technicon Instruments Corp. | CIG |
| Jun 7, 1988 | K881172 | BILIRUBIN (DIRECT) Tech-Co, Inc. | CIG |
| May 27, 1988 | K881241 | TOTAL BILIRUBIN REAGENT Tech-Neal Scientific, Inc. | CIG |
| Apr 28, 1988 | K881166 | DIRECT BILIRUBIN PROCEDURE Data Medical Associates, Inc. | CIG |
| Apr 5, 1988 | K880743 | ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT Abbott Laboratories | CIG |
| Mar 15, 1988 | K880397 | DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. Data Medical Associates, Inc. | CIG |
| Mar 15, 1988 | K880396 | TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. Data Medical Associates, Inc. | CIG |
| Mar 15, 1988 | K880395 | TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU. Data Medical Associates, Inc. | CIG |
| Jan 11, 1988 | K875069 | BILIRUBIN (TOTAL) Tech-Co, Inc. | CIG |
| Nov 25, 1987 | K874311 | MULTICHEM (R) TOTAL BILIRUBIN Simmler, Inc. | CIG |
| Nov 25, 1987 | K874261 | IQ/QCA TOTAL BILIRUBIN Bd Becton Dickinson Vacutainer Systems Preanalytic | CIG |
| Nov 23, 1987 | K872818 | REFLOTRON BILIRUBIN Boehringer Mannheim Corp. | CIG |
| Oct 2, 1987 | K873551 | CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95 Em Diagnostic Systems, Inc. | CIG |
| Sep 14, 1987 | K873424 | EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690 Em Diagnostic Systems, Inc. | CIG |
| Aug 21, 1987 | K872513 | EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604 Em Diagnostic Systems, Inc. | CIG |
| Aug 21, 1987 | K872512 | EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95 Em Diagnostic Systems, Inc. | CIG |
| Aug 21, 1987 | K872487 | VISION(R) TOTAL BILIRUBIN Abbott Laboratories | CIG |
| Aug 19, 1987 | K870365 | DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD Trace Scientific , Ltd., AU | CIG |
| Aug 19, 1987 | K870364 | TOTAL BILIRUBIN REAGENT - DMSO METHOD Trace Scientific , Ltd., AU | CIG |
| Aug 13, 1987 | K872197 | PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT Sigma Diagnostics, Inc. | CIG |
| Jun 3, 1987 | K870095 | BILIRUBIN TESTER Wako Chemicals USA, Inc. | CIG |
| May 18, 1987 | K871531 | REAGENTS 1263,1273,1284,1425,014301,053583 American Research Products Co. | CIG |
| May 14, 1987 | K871530 | TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583 American Research Products Co. | CIG |
| Nov 24, 1986 | K863056 | BILIRUBIN TOTAL J. D. Assoc. | CIG |
| Oct 24, 1986 | K863265 | DIRECT BILIRUBIN PROCEDURE Data Medical Associates, Inc. | CIG |
| Sep 26, 1986 | K863057 | BILIRUBIN TOTAL DIRECT J. D. Assoc. | CIG |
| Sep 17, 1986 | K863262 | TOTAL BILIRUBIN PROCEDURE Data Medical Associates, Inc. | CIG |
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