ALKALINE PHOSPHATASE ISOYZME REAGENT SET— 510(k) K770155

Name: FDA 510(k) clearance K770155
Creator: U.S. Food and Drug Administration
Published: 1977-01-31

Substantially Equivalent

Gelman Instrument Co.

FDA 510(k) clearance K770155 for ALKALINE PHOSPHATASE ISOYZME REAGENT SET, Substantially Equivalent on 1977-01-31. Applicant: Gelman Instrument Co.. Device class: 2.

Clearance details

Applicant: Gelman Instrument Co.
Product code: Code CJO
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1977-01-24
Decision date: 1977-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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