COTUBE LH IRMA ASSAY— 510(k) K884498

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K884498 for COTUBE LH IRMA ASSAY, Substantially Equivalent on 1988-12-22. Applicant: Bio-Rad. Device class: 1.

Clearance details

Applicant: Bio-Rad
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1988-10-26
Decision date: 1988-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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