LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)— 510(k) K884424

Name: FDA 510(k) clearance K884424
Creator: U.S. Food and Drug Administration
Published: 1988-12-15

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K884424 for LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN), Substantially Equivalent on 1988-12-15. Applicant: Bio-Rad. Device class: 1.

Clearance details

Applicant: Bio-Rad
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1988-10-20
Decision date: 1988-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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