CREATINE KINASE REAGENT— 510(k) K803301

Substantially Equivalent

Gilford Diagnostics

FDA 510(k) clearance K803301 for CREATINE KINASE REAGENT, Substantially Equivalent on 1981-01-16. Applicant: Gilford Diagnostics. Device class: 2.

Clearance details

Applicant: Gilford Diagnostics
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1980-12-30
Decision date: 1981-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Gilford Diagnostics

K832094 — BILIRUBIN CALIBRATORS & CONTROL1983-08-11
K831843 — GILCHEM TOTAL BILIRUBIN REAGENT1983-07-18
K831844 — DIRECT BILIRUBIN REAGENT1983-07-18
K823709 — TRIGLYCERIDE REAGENT (UV)1983-01-07
K822739 — AHBD1982-10-18

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