ERYTHROCYTE TEST— 510(k) K832771

Name: FDA 510(k) clearance K832771
Creator: U.S. Food and Drug Administration
Published: 1983-10-28

Substantially Equivalent

Bio-Analytics Laboratories, Inc.

FDA 510(k) clearance K832771 for ERYTHROCYTE TEST, Substantially Equivalent on 1983-10-28. Applicant: Bio-Analytics Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Analytics Laboratories, Inc.
Product code: Code LKZ
Device class: Class 2
Regulation: 21 CFR 864.7100
Advisory panel: Hematology
Date received: 1983-08-16
Decision date: 1983-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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