ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD— 510(k) K921455

Name: FDA 510(k) clearance K921455
Creator: U.S. Food and Drug Administration
Published: 1992-04-29

Substantially Equivalent

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

FDA 510(k) clearance K921455 for ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD, Substantially Equivalent on 1992-04-29. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code CFE
Device class: Class 2
Regulation: 21 CFR 862.1445
Advisory panel: Clinical Chemistry
Date received: 1992-03-27
Decision date: 1992-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

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