Atlas FDA

VIDAS ESTRADIOL II (E2II) ASSAY

FDA 510(k) clearance K955647 · decided 1996-02-06

Clearance details

K-number
K955647
Device name
VIDAS ESTRADIOL II (E2II) ASSAY
Applicant
Biomerieux Vitek, Inc.
Decision
Substantially Equivalent
Date received
1995-12-12
Decision date
1996-02-06
Days to decision
56 days
Clearance type
Traditional
Product code
CHP
Device class
1
Regulation number
862.1260
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Rockland, MA, US
Third-party review
No
Expedited review
No

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RecordFirmDate
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM (K041349)Ibl GmbH2004-09-24
17 B-ESTRADIOL (ELISA) (K973901)Kmi Diagnostics, Inc.1997-11-24
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K973743)Beckman Instruments, Inc.1997-10-31
ACS ESTADIOL-6 II (K970386)Chiron Diagnostics Corp.1997-06-04
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) (K970643)Johnson & Johnson Clinical Diagnostics, Inc.1997-03-18
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) (K970126)Bio-Rad Laboratories, Inc.1997-02-25
ELECSYS ESTRADIOL ASSAY (K965109)Boehringer Mannheim Corp.1997-02-18
CIBA CORNING ACS ESTRADIOL-6 ASSAY (K954697)Ciba Corning Diagnostics Corp.1995-12-13
ULTRA-SENSITIVE ESTRADIOL (K953605)Diagnostic Systems Laboratories, Inc.1995-10-02
ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K951360)Bayer Corp.1995-05-02
AURAFLEX(R) ESTRADIOL (K946199)Organon Teknika Corp.1995-04-03
COAT-A-COUNT(R) ESTRADIOL-6 (K943193)Diagnostic Products Corp.1995-02-23

Recalls involving this device

RecordFirmDate
VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01 recall (Z-0867-2023)Biomerieux Inc2023-01-04
VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intende recall (Z-1801-2017)BioMerieux SA2017-03-20

PMA approvals by this applicant

RecordFirmDate
VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL (N50510/S146)Biomerieux Vitek, Inc.2001-10-17
VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE (N50510/S145)Biomerieux Vitek, Inc.2001-06-25
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN (N50510/S143)Biomerieux Vitek, Inc.2001-06-13
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN (N50510/S144)Biomerieux Vitek, Inc.2001-06-13
VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN (N50510/S142)Biomerieux Vitek, Inc.2001-05-30
VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN (N50510/S141)Biomerieux Vitek, Inc.2001-05-14
VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE (N50510/S140)Biomerieux Vitek, Inc.2001-03-09
VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN (N50510/S138)Biomerieux Vitek, Inc.2000-08-11