Panels › Clinical Chemistry › Product code CHP · Class 1
Radioimmunoassay, Estradiol
Regulation 862.1260
0510(k)s in 12 months (50 all time)
0recalls in 12 months (31 all time)
8recalls that name a 510(k)
Top companies in CHP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2004 | K041349 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM Ibl GmbH | CHP |
| Nov 24, 1997 | K973901 | 17 B-ESTRADIOL (ELISA) Kmi Diagnostics, Inc. | CHP |
| Oct 31, 1997 | K973743 | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc. | CHP |
| Jun 4, 1997 | K970386 | ACS ESTADIOL-6 II Chiron Diagnostics Corp. | CHP |
| Mar 18, 1997 | K970643 | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) Johnson & Johnson Clinical Diagnostics, Inc. | CHP |
| Feb 25, 1997 | K970126 | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) Bio-Rad Laboratories, Inc. | CHP |
| Feb 18, 1997 | K965109 | ELECSYS ESTRADIOL ASSAY Boehringer Mannheim Corp. | CHP |
| Feb 6, 1996 | K955647 | VIDAS ESTRADIOL II (E2II) ASSAY Biomerieux Vitek, Inc. | CHP |
| Dec 13, 1995 | K954697 | CIBA CORNING ACS ESTRADIOL-6 ASSAY Ciba Corning Diagnostics Corp. | CHP |
| Oct 2, 1995 | K953605 | ULTRA-SENSITIVE ESTRADIOL Diagnostic Systems Laboratories, Inc. | CHP |
| May 2, 1995 | K951360 | ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM Bayer Corp. | CHP |
| Apr 3, 1995 | K946199 | AURAFLEX(R) ESTRADIOL Organon Teknika Corp. | CHP |
| Feb 23, 1995 | K943193 | COAT-A-COUNT(R) ESTRADIOL-6 Diagnostic Products Corp. | CHP |
| Sep 7, 1994 | K941168 | CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT Incstar Corp. | CHP |
| Jan 10, 1994 | K932926 | IMMULITE ESTRADIOL Diagnostic Products Corp. | CHP |
| Dec 3, 1993 | K932715 | CIBA CORNING ACS ESTRADIOL IMMUNOASSAY Ciba Corning Diagnostics Corp. | CHP |
| Nov 9, 1993 | K932084 | AIA-PACK E2 ASSAY Tosoh Medics, Inc. | CHP |
| Oct 22, 1993 | K933464 | STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Diagnostics, Inc. | CHP |
| Sep 8, 1993 | K933066 | OPUS ESTRADIOL Pb Diagnostic Systems, Inc. | CHP |
| Aug 16, 1993 | K931740 | COTUBE ESTRADIOL RADIOIMMUNOASSAY Bio-Rad | CHP |
| Feb 12, 1993 | K925498 | VIDAS ESTRADIOL (E2) ASSAY Biomerieux Vitek, Inc. | CHP |
| Feb 18, 1992 | K920047 | IMX ESTRADIOL Abbott Laboratories | CHP |
| Sep 27, 1991 | K913162 | ENZYMUN-TEST ESTRADIOL Boehringer Mannheim Corp. | CHP |
| Jul 30, 1991 | K912917 | MILENIA ESTRADIOL Diagnostic Products Corp. | CHP |
| Jul 25, 1991 | K912318 | ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) Serono-Baker Diagnostics, Inc. | CHP |
| May 28, 1991 | K911396 | SR1 ESTRADIOL ENZYME IMMUNOASSAY Serono-Baker Diagnostics, Inc. | CHP |
| Feb 13, 1991 | K910249 | STRATUS ESTRADIOL FLUOREMETRIC ENZYME Baxter Healthcare Corp | CHP |
| Jun 18, 1990 | K902358 | MODIFIED DELFIA ESTRADIOL KIT Pharmacia, Inc. | CHP |
| Dec 27, 1989 | K896145 | ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. | CHP |
| Dec 12, 1989 | K896270 | AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 Amersham Corp. | CHP |
| Mar 8, 1989 | K890645 | ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT Serono-Baker Diagnostics, Inc. | CHP |
| Nov 16, 1988 | K884105 | AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT) Amersham Corp. | CHP |
| Jul 1, 1988 | K882343 | TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT Terumo Medical Corp. | CHP |
| Jun 24, 1988 | K882173 | DELFIA ESTRADIOL KIT Pharmacia, Inc. | CHP |
| Feb 18, 1988 | K873550 | DSL ACTIVE ESTRADIOL RIA (DSL #4300) Diagnostic Systems Laboratories, Inc. | CHP |
| Jun 8, 1987 | K870405 | DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400) Diagnostic Systems Laboratories, Inc. | CHP |
| Aug 19, 1986 | K862603 | DOUBLE ANTIBODY ESTRADIOL RIA KIT Diagnostic Products Corp. | CHP |
| Jun 27, 1986 | K861361 | ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE Serono Diagnostics, Inc. | CHP |
| Oct 15, 1985 | K853866 | PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS Pantex, Div. Bio-Analysis, Inc. | CHP |
| Aug 19, 1985 | K853208 | 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY Travenol Laboratories, S.A. | CHP |
| Jun 6, 1985 | K851540 | ESTRADIOL DIRECT RIA KIT Biotecx Laboratories, Inc. | CHP |
| Jun 25, 1984 | K841947 | ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT Sorin Biomedica, Fiat, USA, Inc. | CHP |
| Mar 23, 1984 | K840051 | COAT-A-COUNT ESTRADIOL KIT Diagnostic Products Corp. | CHP |
| Mar 9, 1984 | K834586 | LEECO E2 QUANT DIAG. TEST KIT Leeco Diagnostics, Inc. | CHP |
| Mar 4, 1982 | K820329 | ESTRADIOL KIT BY RIA Immuchem Corp. | CHP |
| Mar 31, 1981 | K810695 | ESTRIOL RADIOIMMUNOASSAY TEST KIT Serono Laboratories, Inc. | CHP |
| Mar 27, 1981 | K810204 | 17B ESTRADIOL Pantex, Div. Bio-Analysis, Inc. | CHP |
| May 14, 1980 | K800920 | NORDICLAB ESTRADIOL RIA TEST Nordiclab Intl. | CHP |
| Sep 27, 1979 | K791652 | ESTRADIOL KIT BY RIA Radioassay Systems Laboratories, Inc. | CHP |
| May 23, 1979 | K790679 | ESTRADIOL RIA KIT Serono Laboratories, Inc. | CHP |
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