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CIG

235 FDA 510(k) clearances · Product code

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RecordFirmDate
OLYMPUS(TM) TOTAL BILIRUBIN (K897174)Em Diagnostic Systems, Inc.1990-05-10
COULTER TOTAL BILIRUBIN REAGENT (K901266)Coulter Corp.1990-04-25
AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) (K900571)American Research Products Co.1990-04-16
SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX (K897176)Em Diagnostic Systems, Inc.1990-03-19
OLYMPUS DIRECT BILIRUBIN (K897175)Em Diagnostic Systems, Inc.1990-03-15
DIRECT BILIRUBIN REAGENT (K900259)Medical Analysis Systems, Inc.1990-02-27
COBAS READY TOTAL BILIRUBIN REAGENT (K896232)Roche Diagnostic Systems, Inc.1990-02-27
TOTAL BILIRUBIN L.F. (K895822)Sclavo, Inc.1989-11-14
SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406 (K895119)Em Diagnostic Systems, Inc.1989-10-17
SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407 (K895118)Em Diagnostic Systems, Inc.1989-10-17
CLINISTAT TOTAL BILIRUBIN REAGENT TEST (K892801)Heraeus Kulzer, Inc.1989-08-15
DIRECT BILIRUBIN REAGENT (K893730)Medical Analysis Systems, Inc.1989-08-11
TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS (K892668)Catachem, Inc.1989-07-20
DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI. (K892905)Catachem, Inc.1989-06-19
DIRECT BILIRUBIN FOR CONTINUOUS FLOW (K891240)Catachem, Inc.1989-05-10
TOTAL BILIRUBIN FOR CONTINUOUS FLOW (K891025)Catachem, Inc.1989-04-04
TOTAL BILIRUBIN REAGENT, CONCENTRATED (K890070)Trace Scientific , Ltd.1989-03-06
TOTAL BILIRUBIN TEST CATALOG NO. SR1007 (K885284)Em Diagnostic Systems, Inc.1989-01-30
DIRECT BILIRUBIN TEST CATALOG NO. SR1008 (K885285)Em Diagnostic Systems, Inc.1989-01-30
UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON. (K871115)Labo Science-USA, Inc.1989-01-27
TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS (K884224)A-Kem, Inc.1988-12-15
VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM (K880437)Abbott Laboratories1988-08-03
DIAZO, COLORIMETRIC BILIRUBIN (K882459)Tech-Neal Scientific, Inc.1988-08-02
TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN (K881798)Technicon Instruments Corp.1988-06-07
BILIRUBIN (DIRECT) (K881172)Tech-Co, Inc.1988-06-07
TOTAL BILIRUBIN REAGENT (K881241)Tech-Neal Scientific, Inc.1988-05-27
DIRECT BILIRUBIN PROCEDURE (K881166)Data Medical Associates, Inc.1988-04-28
ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT (K880743)Abbott Laboratories1988-04-05
TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU. (K880395)Data Medical Associates, Inc.1988-03-15
DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. (K880397)Data Medical Associates, Inc.1988-03-15
TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. (K880396)Data Medical Associates, Inc.1988-03-15
BILIRUBIN (TOTAL) (K875069)Tech-Co, Inc.1988-01-11
MULTICHEM (R) TOTAL BILIRUBIN (K874311)Simmler, Inc.1987-11-25
IQ/QCA TOTAL BILIRUBIN (K874261)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-11-25
REFLOTRON BILIRUBIN (K872818)Boehringer Mannheim Corp.1987-11-23
CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95 (K873551)Em Diagnostic Systems, Inc.1987-10-02
EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690 (K873424)Em Diagnostic Systems, Inc.1987-09-14
EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604 (K872513)Em Diagnostic Systems, Inc.1987-08-21
EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95 (K872512)Em Diagnostic Systems, Inc.1987-08-21
VISION(R) TOTAL BILIRUBIN (K872487)Abbott Laboratories1987-08-21
DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD (K870365)Trace Scientific , Ltd.1987-08-19
TOTAL BILIRUBIN REAGENT - DMSO METHOD (K870364)Trace Scientific , Ltd.1987-08-19
PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT (K872197)Sigma Diagnostics, Inc.1987-08-13
BILIRUBIN TESTER (K870095)Wako Chemicals USA, Inc.1987-06-03
REAGENTS 1263,1273,1284,1425,014301,053583 (K871531)American Research Products Co.1987-05-18
TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583 (K871530)American Research Products Co.1987-05-14
BILIRUBIN TOTAL (K863056)J. D. Assoc.1986-11-24
DIRECT BILIRUBIN PROCEDURE (K863265)Data Medical Associates, Inc.1986-10-24
BILIRUBIN TOTAL DIRECT (K863057)J. D. Assoc.1986-09-26
TOTAL BILIRUBIN PROCEDURE (K863262)Data Medical Associates, Inc.1986-09-17
BILIFAST (K863055)J. D. Assoc.1986-09-09
METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM (K862359)E.I. Dupont DE Nemours & Co., Inc.1986-08-19
AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS (K862299)Amresco, Inc.1986-07-01
TOTAL BILIRUBIN TEST KIT (K861998)Ciba Corning Diagnostics Corp.1986-06-27
DIRECT BILIRUBIN PROCEDURE (K861671)Data Medical Associates, Inc.1986-06-25
TOTAL BILIRUBIN PROCEDURE (K861651)Data Medical Associates, Inc.1986-05-29
BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET (K861413)Medical Analysis Systems, Inc.1986-04-24
BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04 (K861095)Diagnostic Chemicals, Ltd. (Usa)1986-04-21
BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02 (K861094)Diagnostic Chemicals, Ltd. (Usa)1986-04-21
A-GENT LIQUID TOTAL BILIRUBIN (K860424)Abbott Laboratories1986-04-03
TOTAL BILIRUBIN REAGENT SET (K860214)Sterling Diagnostics, Inc.1986-03-17
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95 (K855079)Em Diagnostic Systems, Inc.1986-03-05
DIRECT BILIRUBIN (K860257)Pointe Scientific, Inc.,1986-02-21
DIRECT & TOTAL BILIRUBIN SET (K855195)Technostics Intl.1986-01-14
IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN (K854180)Clinical Data, Inc.1985-11-25
T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL (K852008)Alpkem Corp.1985-05-30
ABBOTT TDT EIA (K843908)Abbott Laboratories1985-04-03
I-L TEST, DIRECT BILIRUBIN SET (K850748)Allied Instrumentation Laboratory1985-04-03
DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE (K850901)Data Medical Associates, Inc.1985-04-01
DIRECT BILIRUBIN FOR DEMAND ANALYZER (K850379)Advanced Biomedical Methods, Inc.1985-03-01
SYSTEMATE D-BILI 67213 (K843329)Em Diagnostic Systems, Inc.1984-09-20
SYSTEMATE T-BILI 67212 (K843328)Em Diagnostic Systems, Inc.1984-09-20
TOTAL BILIRUBIN TEST (K843178)Sclavo, Inc.1984-09-07
BILIRUBIN ASSAY KIT - TOTAL (K843032)Diagnostic Chemicals, Ltd. (Usa)1984-09-04
BILIRUBIN ASSAY KIT DIRECT (K843027)Diagnostic Chemicals, Ltd. (Usa)1984-09-04
TECHNICON RA-1000 SYS, DIRECT BILIRUBIN (K842809)Technicon Instruments Corp.1984-08-17
ACA CONJUGATED BILIRUBIN ANALYTICAL (K842385)E.I. Dupont DE Nemours & Co., Inc.1984-08-17
RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT (K841892)Reagents Applications, Inc.1984-06-07
ELVI 444 BILITRON (K840757)Logos Scientific, Inc.1984-05-30
DIRECT BILIRUBIN REAGENT (K841572)Hi Chem, Inc.1984-05-16
TOTAL BILIRUBIN REAGENT SET (K841050)Medical Specialties, Inc.1984-05-01
TOTAL BILIRUBIN REAGENT (K840486)Somas Medical Industries, Inc.1984-04-25
EKTACHEM CLINICAL CHEM. SLIDES (K840880)Eastman Kodak Company1984-04-18
NEONATAL BILIRUBIN REAGENT (K840779)American Dade1984-04-13
DIRECT BILIRUBIN REAGENT (K840777)American Dade1984-04-05
EKTACHEM CLINICAL CHEM. SLIDES (K840606)Eastman Kodak Company1984-04-04
TOTAL BILIRUBIN (K840111)Fisher Scientific Co., LLC1984-03-19
LIQUI ZYME TOTAL BILIRUBIN REAGENT (K840564)American Research Products Co.1984-03-09
TOTAL & DIRECT BILIRUBIN PROCEDURES (K832942)Sandare Chemical Co., Inc.1983-11-07
PARAMAX TOTAL BILIRUBIN REAGENT (K833004)American Dade1983-10-14
COMPUR* EASYTOUCH TOTAL BILIRUBIN (K832748)Worthington Diagnostic Systems1983-10-14
DIAZO COLORIMETRY, BILLIRUBIN (K832870)Pointe Scientific, Inc.,1983-09-26
ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK (K832357)E.I. Dupont DE Nemours & Co., Inc.1983-09-01
SIGMA PROCEDURE #550 DETERM. BILIRUB (K832236)Sigma Chemical Co.1983-08-31
GILCHEM TOTAL BILIRUBIN REAGENT (K831843)Gilford Diagnostics1983-07-18
DIRECT BILIRUBIN REAGENT (K831844)Gilford Diagnostics1983-07-18
TOTAL BILIRUBIN REAGENT (K830714)Hi Chem, Inc.1983-04-06
ULTRACHEM T-BILI (K821873)Harleco Diagnostics1982-07-14
TOTAL BILIRUBIN REAGENT SET (K821197)Omega Medical Electronics1982-07-13
ULTRACHEM T-BILI, #64971 (K821462)Emd Chemicals, Inc.1982-06-01
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