CHEM-STRATE CK-NAC— 510(k) K792477

Substantially Equivalent

General Diagnostics

FDA 510(k) clearance K792477 for CHEM-STRATE CK-NAC, Substantially Equivalent on 1979-12-27. Applicant: General Diagnostics. Device class: 2.

Clearance details

Applicant: General Diagnostics
Product code: Product code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1979-12-03
Decision date: 1979-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGS

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 General Diagnostics

K882663 — BARBITURATE ENZYME IMMUNOASSAY KIT1988-09-19
K872882 — CANNABINOID ENZYME IMMUNOASSAY KIT1987-11-03
K871305 — COCAINE METABOLITE ENZYME IMMUNOASSAY KIT1987-06-05
K864993 — QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE1987-03-31
K863877 — BENZODIAZEPINE ENZYME IMMUNOASSAY KIT1987-03-12

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