SERA-PAK TOTAL PROTEIN REAGENT— 510(k) K802742

Name: FDA 510(k) clearance K802742
Creator: U.S. Food and Drug Administration
Published: 1980-12-11

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K802742 for SERA-PAK TOTAL PROTEIN REAGENT, Substantially Equivalent on 1980-12-11. Applicant: Miles Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code GGK
Device class: Class 1
Regulation: 21 CFR 864.8540
Advisory panel: Hematology
Date received: 1980-11-03
Decision date: 1980-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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