GILCHEM ACID PHOSPHATASE REAGENT— 510(k) K820975

Name: FDA 510(k) clearance K820975
Creator: U.S. Food and Drug Administration
Published: 1982-04-26

Substantially Equivalent

Gilford Diagnostics

FDA 510(k) clearance K820975 for GILCHEM ACID PHOSPHATASE REAGENT, Substantially Equivalent on 1982-04-26. Applicant: Gilford Diagnostics. Device class: 2.

Clearance details

Applicant: Gilford Diagnostics
Product code: Code CKB
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1982-04-06
Decision date: 1982-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K823709 — TRIGLYCERIDE REAGENT (UV)1983-01-07
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