QUANTIFY(901)— 510(k) K972710

Substantially Equivalent

Hematronix, Inc.

FDA 510(k) clearance K972710 for QUANTIFY(901), Substantially Equivalent on 1997-08-15. Applicant: Hematronix, Inc.. Device class: 1.

Clearance details

Applicant: Hematronix, Inc.
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1997-07-21
Decision date: 1997-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Benicia, CA, US

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