Atlas FDA

AURAFLEX PROGESTERONE 150TEST PACK

FDA 510(k) clearance K951630 · decided 1995-05-08

Clearance details

K-number
K951630
Device name
AURAFLEX PROGESTERONE 150TEST PACK
Applicant
Organon Teknika Corp.
Decision
Substantially Equivalent
Date received
1995-04-07
Decision date
1995-05-08
Days to decision
31 days
Clearance type
Traditional
Product code
JLS
Device class
1
Regulation number
862.1620
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Durham, NC, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Organon Teknika Corp.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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 PROGESTERONE IN SALIVA (K040923)Ibl GmbH2004-07-22
PROGESTERONE ELISA (K973898)Kmi Diagnostics, Inc.1997-11-13
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) (K972133)Johnson & Johnson Clinical Diagnostics, Inc.1997-06-24
OPUS PROGESTERONE (K971725)Behring Diagnostics, Inc.1997-06-18
ELECSYS PROGESTERONE ASSAY (K964841)Boehringer Mannheim Corp.1997-03-24
VIDAS PROESTERONE (PRG) (30 409) (K965084)bioMerieux, Inc.1997-01-09
AXSYM PROGESTERONE (K955025)Abbott Laboratories1996-03-07
ACCESS PROGESTERONE ASSAY (K955769)Bio-Rad Laboratories, Inc.1996-02-05
PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM (K952075)Bayer Corp.1995-06-13
STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY (K950570)Baxter Diagnostics, Inc.1995-04-11
IMMULITE PROGESTERONE (K944211)Diagnostic Products Corp.1994-12-19
IMMULITE PROGESTERONE (K935138)Diagnostic Products Corp.1994-01-11

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