SICKLE-CHECK— 510(k) K820037

Substantially Equivalent

Diagnostic Technology, Inc.

FDA 510(k) clearance K820037 for SICKLE-CHECK, Substantially Equivalent on 1982-02-04. Applicant: Diagnostic Technology, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Technology, Inc.
Product code: Code JCM
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 1982-01-07
Decision date: 1982-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.