Atlas FDA

PARAMAX ASPARTATE AMINOTRANSFERASE REAGENT

FDA 510(k) clearance K901104 · decided 1990-03-23

Clearance details

K-number
K901104
Device name
PARAMAX ASPARTATE 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
CIT
Device class
2
Regulation number
862.1100
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Santa Ana, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Baxter Healthcare 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
AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- (K093883)Seppim S.A.S.2010-09-20
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS (K080485)Diasys Diagnostics Systems GmbH2008-12-04
ACTIVATED ASPARTATE AMINOTRANSFERASE (K071525)Abbott Laboratories2008-03-19
AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL (K071580)Thermofisher Scientific OY2007-10-03
COBAS C 111 ANALYZER (K071211)Roche Diagnostics2007-07-30
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (K060318)Horiba Abx2006-08-08
WIENER LAB GOT (AST) UV AA LIQUIDA (K023551)Wiener Laboratories Saic2002-12-09
AST (SGOT) (K013698)Jas Diagnostics, Inc.2001-12-21
WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. (K013145)Wiener Laboratories Saic2001-11-27
ATAC PAK AST REAGENT KIT (K010488)Elan Holdings, Inc.2001-04-09
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 (K001679)Ortho-Clinical Diagnostics, Inc.2000-06-28
WAKO L-TYPE GOT TEST (K993468)Wako Chemicals USA, Inc.1999-12-16

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