HEMOGLOBIN A2 MICRO COLUMN TEST— 510(k) K896168

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K896168 for HEMOGLOBIN A2 MICRO COLUMN TEST, Substantially Equivalent on 1990-01-18. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code JPD
Device class: Class 2
Regulation: 21 CFR 864.7400
Advisory panel: Hematology
Date received: 1989-10-25
Decision date: 1990-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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