RAICHEM TM CREATINE KINASE REAGENT— 510(k) K820644

Name: FDA 510(k) clearance K820644
Creator: U.S. Food and Drug Administration
Published: 1982-04-01

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K820644 for RAICHEM TM CREATINE KINASE REAGENT, Substantially Equivalent on 1982-04-01. Applicant: Reagents Applications, Inc.. Device class: 2.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1982-03-09
Decision date: 1982-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGS

view all

K191296 — Pointe Scientific Creatinine Kinase (CK) Reagent Set2020-08-11
K182702 — SEKURE Creatine Kinase Assay2019-04-17
K160724 — ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator2016-09-07
K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR2013-11-21
K112416 — CPK REAGENT2011-11-09

More clearances from Reagents Applications, Inc.

view all

K982056 — RAICHEM CO2 REAGENT1998-06-24
K972853 — CHOLESTEROL RAPID LIQUID REAGENT1997-09-24
K922904 — RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II1992-07-30
K915191 — RAI-TROL ELEVATED LIPIDS CONTROL1991-12-18
K913398 — RAICHEM(TM) CREATINE KINASE-MB REAGENT1991-09-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.