ELAN ALKALINE PHOSPHATE REAGENT KIT— 510(k) K991387

Name: FDA 510(k) clearance K991387
Creator: U.S. Food and Drug Administration
Published: 1999-05-19

Substantially Equivalent

Elan Holdings, Inc.

FDA 510(k) clearance K991387 for ELAN ALKALINE PHOSPHATE REAGENT KIT, Substantially Equivalent on 1999-05-19. Applicant: Elan Holdings, Inc.. Device class: 2.

Clearance details

Applicant: Elan Holdings, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1999-04-21
Decision date: 1999-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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