IMACK-MB TEST PROCEDURE (MODIFICATION)— 510(k) K874545

Name: FDA 510(k) clearance K874545
Creator: U.S. Food and Drug Administration
Published: 1987-12-18

Substantially Equivalent

Intl. Immunoassay Laboratories, Inc.

FDA 510(k) clearance K874545 for IMACK-MB TEST PROCEDURE (MODIFICATION), Substantially Equivalent on 1987-12-18. Applicant: Intl. Immunoassay Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Immunoassay Laboratories, Inc.
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1987-11-03
Decision date: 1987-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

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