LABELLING CHANGES TO IMPRES-MB-X— 510(k) K903508

Name: FDA 510(k) clearance K903508
Creator: U.S. Food and Drug Administration
Published: 1990-09-07

Substantially Equivalent

Intl. Immunoassay Laboratories, Inc.

FDA 510(k) clearance K903508 for LABELLING CHANGES TO IMPRES-MB-X, Substantially Equivalent on 1990-09-07. Applicant: Intl. Immunoassay Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Immunoassay Laboratories, Inc.
Product code: Code JHW
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1990-07-31
Decision date: 1990-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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