Raichem Gpt (Alt) Reagent

by Reagents Applications, Inc. 510(k)

Active United States

510(k) K820525

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK820525	Date15 Mar 1982Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K820525
FDA Product Code: CKA

Device Class: Class I
Regulation: 21 CFR Part 862.1030
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

Other devices from Reagents Applications, Inc.

Total Protein Reagent Biuret

Class II
Raichem Creatine Kinase Reagent, Optimized UV

Class II
Raichem Acid Phosphatase Reagent

Class II
Raichem Spia Apo B Reagents

Class II
Raichem(Tm) Spia(Tm) Igm Reagents

Class II
Uric Acid Reagent-Enzymatic-Color-520 Nm

Class I

See all devices from Reagents Applications, Inc. →