HIPP BUFFER(NON-BARBITAL), P/N— 510(k) K801378

Name: FDA 510(k) clearance K801378
Creator: U.S. Food and Drug Administration
Published: 1980-07-14

Substantially Equivalent

Gelman Sciences, Inc.

FDA 510(k) clearance K801378 for HIPP BUFFER(NON-BARBITAL), P/N, Substantially Equivalent on 1980-07-14. Applicant: Gelman Sciences, Inc.. Device class: 1.

Clearance details

Applicant: Gelman Sciences, Inc.
Product code: Code JJN
Device class: Class 1
Regulation: 21 CFR 862.2485
Advisory panel: Clinical Chemistry
Date received: 1980-06-11
Decision date: 1980-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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