VARIANT II TOTAL GHB— 510(k) K003280

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K003280 for VARIANT II TOTAL GHB, Substantially Equivalent on 2000-12-19. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2000-10-19
Decision date: 2000-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, 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.