Atlas FDA

AURAFLEX(R) ESTRADIOL

FDA 510(k) clearance K946199 · decided 1995-04-03

Clearance details

K-number
K946199
Device name
AURAFLEX(R) ESTRADIOL
Applicant
Organon Teknika Corp.
Decision
Substantially Equivalent
Date received
1994-12-20
Decision date
1995-04-03
Days to decision
104 days
Clearance type
Traditional
Product code
CHP
Device class
1
Regulation number
862.1260
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Durham, NC, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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
VIDAS ESTRADIOL II (E2II) ASSAY (K955647)Biomerieux Vitek, Inc.1996-02-06
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
COAT-A-COUNT(R) ESTRADIOL-6 (K943193)Diagnostic Products Corp.1995-02-23

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018/S001)Organon Teknika Corp.1990-03-21
HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST (P840070/S001)Organon Teknika Corp.1990-03-21
9EPANOSTIKA(TM) ANTI-HAV IGM (P830017/S001)Organon Teknika Corp.1990-03-21
AUTOBAC MIC TEST SYSTEM (N50524/S033)Organon Teknika Corp.1990-01-22
AUTOBAC MIC TEST SYSTEM (N50524/S035)Organon Teknika Corp.1989-12-07
AUTOBAC MIC TEST SYSTEM (N50524/S032)Organon Teknika Corp.1989-06-13
HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018)Organon Teknika Corp.1989-02-06
AUTOBAC MIC TEST SYSTEM (N50524/S031)Organon Teknika Corp.1988-12-28