Atlas FDA

PARAMAX PHOSPHORUS REAGENT

FDA 510(k) clearance K873454 · decided 1987-11-23

Clearance details

K-number
K873454
Device name
PARAMAX PHOSPHORUS REAGENT
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1987-08-28
Decision date
1987-11-23
Days to decision
87 days
Clearance type
Traditional
Product code
CEO
Device class
1
Regulation number
862.1580
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
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS (K100263)Seppim S.A.S.2011-05-06
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA (K072141)Alfa Wassermann Diagnostic Technologies, Inc.2008-06-24
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT (K041643)Beckman Coulter, Inc.2004-08-18
ATAC PAK PHOSPHORUS REAGENT (K030015)Elan Diagnostics2003-03-07
PICCOLO PHOSPHORUS TEST SYSTEM (K022312)Abaxis, Inc.2002-09-05
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 (K013095)Wiener Laboratories Saic2001-11-16
PHOSPHORUS REAGENT (K003912)Jas Diagnostics, Inc.2001-02-21
RAICHEM PHOSPORUS REAGENT (K003012)Hemagen Diagnostics, Inc.2000-10-25
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (K991867)A.P. Total Care, Inc.1999-08-02
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 (K983503)Boehringer Mannheim Corp.1998-12-01
HICHEM PHOSPHORUS REAGENT KIT (K981769)Elan Pharma, Inc.1998-06-29
CARESIDE ANALYZER (K981610)Careside, Inc.1998-06-25

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