ISOFOR-MM (TM)— 510(k) K883222

Name: FDA 510(k) clearance K883222
Creator: U.S. Food and Drug Administration
Published: 1988-09-30

Substantially Equivalent

Intl. Immunoassay Laboratories, Inc.

FDA 510(k) clearance K883222 for ISOFOR-MM (TM), Substantially Equivalent on 1988-09-30. 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: 1988-07-29
Decision date: 1988-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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