Atlas FDA

MODIFIED PARAMAX GLUCOSE REAGENT

FDA 510(k) clearance K873936 · decided 1987-11-23

Clearance details

K-number
K873936
Device name
MODIFIED PARAMAX GLUCOSE REAGENT
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1987-09-25
Decision date
1987-11-23
Days to decision
59 days
Clearance type
Traditional
Product code
CFR
Device class
2
Regulation number
862.1345
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
Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (K253490)Roche Diagnostics2026-02-12
Glucose2 (K252357)Abbott Ireland2025-10-24
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH (K220134)Roche Diagnostics2022-09-16
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions (K191899)Roche Diagnostics2019-08-16
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM (K170316)Abbott Laboratories2017-10-19
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II (K153644)Elitechgroup2016-09-07
Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method (K151487)Diatron U.S., Inc.2016-01-14
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) (K131189)Beckman Coulter, Inc.2014-04-17
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE (K123018)Alfa Wassermann Diagnostic Technologies, Inc.2013-04-23
ADVIA CHEMISTRY GLUH_3 REAGENTS (K120681)Siemens Healthcare Diagnostics, Inc.2012-05-15
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) (K120369)Hitachi Chemical Diagnostics, Inc.2012-05-10
BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER (K112377)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2012-03-23

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