ENZYME IMMUNOASSAY FOR DETECTION HORM— 510(k) K841545

Name: FDA 510(k) clearance K841545
Creator: U.S. Food and Drug Administration
Published: 1984-11-27

Substantially Equivalent

Btc Diagnostics, Inc.

FDA 510(k) clearance K841545 for ENZYME IMMUNOASSAY FOR DETECTION HORM, Substantially Equivalent on 1984-11-27. Applicant: Btc Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Btc Diagnostics, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1984-04-16
Decision date: 1984-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.