VARIANT TOTAL GHB PROGRAM— 510(k) K941616

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K941616 for VARIANT TOTAL GHB PROGRAM, Substantially Equivalent on 1995-04-14. 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: 1994-04-04
Decision date: 1995-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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