BHCG-CHECK— 510(k) K834346

Substantially Equivalent

Diagnostic Technology, Inc.

FDA 510(k) clearance K834346 for BHCG-CHECK, Substantially Equivalent on 1984-02-04. Applicant: Diagnostic Technology, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Technology, Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1983-12-12
Decision date: 1984-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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