IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225— 510(k) K881351

Name: FDA 510(k) clearance K881351
Creator: U.S. Food and Drug Administration
Published: 1988-06-01

Substantially Equivalent

Intl. Immunoassay Laboratories, Inc.

FDA 510(k) clearance K881351 for IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225, Substantially Equivalent on 1988-06-01. 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: 1988-03-30
Decision date: 1988-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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