CREATINE PHOSPHOKINASE (CPK)— 510(k) K780504

Name: FDA 510(k) clearance K780504
Creator: U.S. Food and Drug Administration
Published: 1978-05-03

Substantially Equivalent

Gamma Enterprises, Inc.

FDA 510(k) clearance K780504 for CREATINE PHOSPHOKINASE (CPK), Substantially Equivalent on 1978-05-03. Applicant: Gamma Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Gamma Enterprises, Inc.
Product code: Code JHS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1978-03-30
Decision date: 1978-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHS

view all

K160570 — Creatine Kinase2016-05-25
K102706 — CKMB UDR ASSAY2011-08-19
K082226 — S40 CREATINE KINASE (CK)2008-09-18
K062128 — THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS2006-08-21
K990434 — CARESIDE CKMB1999-04-19

More clearances from Gamma Enterprises, Inc.

view all

K790578 — GAMMA SMAC REAGENTS1979-05-15
K780505 — SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE1978-05-03
K780506 — CARBON DIOXIDE REAGENTS1978-05-03
K780507 — SERUM GLUTAMIC-PYRUVIC TRANSAMINASE1978-05-03
K771832 — CHLORIDE1977-11-22

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