Atlas FDA

STRATUS ESTRADIOL FLUOREMETRIC ENZYME

FDA 510(k) clearance K910249 · decided 1991-02-13

Clearance details

K-number
K910249
Device name
STRATUS ESTRADIOL FLUOREMETRIC ENZYME
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1991-01-22
Decision date
1991-02-13
Days to decision
22 days
Clearance type
Traditional
Product code
CHP
Device class
1
Regulation number
862.1260
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Miami, FL, 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
AURAFLEX(R) ESTRADIOL (K946199)Organon Teknika Corp.1995-04-03

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077)Baxter Healthcare Corp2025-11-13
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076)Baxter Healthcare Corp2025-06-30
Floseal Hemostatic Matrix (P990009/S075)Baxter Healthcare Corp2025-01-30
Adept Adhesion Reduction Solution (P050011/S009)Baxter Healthcare Corp2024-08-23
Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074)Baxter Healthcare Corp2024-08-15
Floseal Hemostatic Matrix (P990009/S073)Baxter Healthcare Corp2024-01-10
Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072)Baxter Healthcare Corp2023-12-12
Floseal Hemostatic Matrix, RT5 (P990009/S070)Baxter Healthcare Corp2023-02-02