TANDEM PROLACTIN KIT— 510(k) K821545

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K821545 for TANDEM PROLACTIN KIT, Substantially Equivalent on 1982-06-11. Applicant: Hybritech, Inc.. Device class: 1.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1982-05-25
Decision date: 1982-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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