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

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..

Clearance details

Applicant: Intl. Immunoassay Laboratories, Inc.
Product code: Code JHW
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

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