Atlas FDA

PROLACTIN (LACTOGEN) TEST SYSTEM

FDA 510(k) clearance K901673 · decided 1990-06-12

Clearance details

K-number
K901673
Device name
PROLACTIN (LACTOGEN) TEST SYSTEM
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1990-04-10
Decision date
1990-06-12
Days to decision
63 days
Clearance type
Traditional
Product code
CFT
Device class
1
Regulation number
862.1625
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
PROLACTIN (PRL) HORMONE MICROPLATE ELISA (K971921)Monobind1997-06-24
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (K970281)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-25
SEALITE SCIENCES, INC. AQUALITE PROLACTIN (K970188)Sealite Sciences, Inc.1997-02-20
ELECSYS PROLACTIN ASSAY (K964748)Boehringer Mannheim Corp.1997-01-21
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 (K960561)Diagnostic Systems Laboratories, Inc.1996-04-26
DSL ACTIVE PROLACTIN IRMA (K960060)Diagnostic Systems Laboratories, Inc.1996-02-29
ACCESS PROLACTIN ASSAY (MODIFICATION) (K954680)Bio-Rad Laboratories, Inc.1995-10-20
ABBOTT IMX PROLACTIN(MODIFICATION) (K953656)Abbott Mfg., Inc.1995-10-03
ABBOTT AXSYM PROLACTIN(MODIFICATION) (K953657)Abbott Mfg., Inc.1995-09-25
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 (K944698)Organon Teknika Corp.1995-03-21
ENZYME-LINKED FLUORESCENT IMMUNOASSAY (K943811)Biomerieux Vitek, Inc.1994-11-02
AXSYM PROLACTIN (K935675)Abbott Laboratories1994-06-21

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