ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI— 510(k) K905820

Name: FDA 510(k) clearance K905820
Creator: U.S. Food and Drug Administration
Published: 1991-02-26

Substantially Equivalent

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

FDA 510(k) clearance K905820 for ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI, Substantially Equivalent on 1991-02-26. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1990-12-31
Decision date: 1991-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

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