DIACROM * ATIII— 510(k) K832592

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K832592 for DIACROM * ATIII, Substantially Equivalent on 1983-09-29. Applicant: Wellcome Diagnostics. Device class: 2.

Clearance details

Applicant: Wellcome Diagnostics
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1983-08-02
Decision date: 1983-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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