HCG-CHECK— 510(k) K831466

Substantially Equivalent

Diagnostic Technology, Inc.

FDA 510(k) clearance K831466 for HCG-CHECK, Substantially Equivalent on 1983-06-22. 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: 1983-05-06
Decision date: 1983-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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