ACA LIPASE ANALYTICAL TEST PACK— 510(k) K770364

Name: FDA 510(k) clearance K770364
Creator: U.S. Food and Drug Administration
Published: 1977-04-15

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K770364 for ACA LIPASE ANALYTICAL TEST PACK, Substantially Equivalent on 1977-04-15. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 1.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code CET
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1977-02-23
Decision date: 1977-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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