MACRALP(A) ENZYME IMMUNOASSAY KIT— 510(k) K971157

Name: FDA 510(k) clearance K971157
Creator: U.S. Food and Drug Administration
Published: 1998-04-15

Substantially Equivalent

Strategic Diagnostics, Inc.

FDA 510(k) clearance K971157 for MACRALP(A) ENZYME IMMUNOASSAY KIT, Substantially Equivalent on 1998-04-15. Applicant: Strategic Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Strategic Diagnostics, Inc.
Product code: Code JHO
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1997-03-28
Decision date: 1998-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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