Atlas FDA

PARAMAX ALANINE AMINOTRANSFERASE REAGENT

FDA 510(k) clearance K901105 · decided 1990-03-23

Clearance details

K-number
K901105
Device name
PARAMAX ALANINE AMINOTRANSFERASE REAGENT
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1990-03-08
Decision date
1990-03-23
Days to decision
15 days
Clearance type
Traditional
Product code
CKA
Device class
1
Regulation number
862.1030
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Santa Ana, CA, US
Third-party review
No
Expedited review
No

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ALT OR SGPT (K971323)Carolina Liquid Chemistries Corp.1997-04-21
ALT/SGPT (K965134)Derma Media Lab., Inc.1997-02-18
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CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE (K952427)Beckman Instruments, Inc.1995-09-21
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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