THROMBIN CLOTTING TIME— 510(k) K811109

Substantially Equivalent

Bio/Data Corp.

FDA 510(k) clearance K811109 for THROMBIN CLOTTING TIME, Substantially Equivalent on 1981-07-16. Applicant: Bio/Data Corp.. Device class: 2.

Clearance details

Applicant: Bio/Data Corp.
Product code: Code GJA
Device class: Class 2
Regulation: 21 CFR 864.7875
Advisory panel: Hematology
Date received: 1981-04-23
Decision date: 1981-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.