125I QUICK-MB TEST KIT FOR QUANTITATION— 510(k) K821964

Substantially Equivalent

Intl. Immunoassay Laboratories, Inc.

FDA 510(k) clearance K821964 for 125I QUICK-MB TEST KIT FOR QUANTITATION, Substantially Equivalent on 1982-07-22. Applicant: Intl. Immunoassay Laboratories, Inc.. Device class: 2.

Clearance details

Applicant
Intl. Immunoassay Laboratories, Inc.
Product code
Code JHT
Device class
Class 2
Regulation
21 CFR 862.1215
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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