PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT— 510(k) K912231

Name: FDA 510(k) clearance K912231
Creator: U.S. Food and Drug Administration
Published: 1991-07-08

Substantially Equivalent

Intl. Immunoassay Laboratories, Inc.

FDA 510(k) clearance K912231 for PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT, Substantially Equivalent on 1991-07-08. 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: 1991-05-20
Decision date: 1991-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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