SICKLE HB ASSAY— 510(k) K841170

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K841170 for SICKLE HB ASSAY, Substantially Equivalent on 1984-04-04. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code GHM
Device class: Class 2
Regulation: 21 CFR 864.7825
Advisory panel: Hematology
Date received: 1984-03-19
Decision date: 1984-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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