TANDEM - EPRL— 510(k) K843804

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K843804 for TANDEM - EPRL, Substantially Equivalent on 1984-11-13. 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: 1984-09-27
Decision date: 1984-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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