HELA-229/HELA CELLS— 510(k) K934973

Name: FDA 510(k) clearance K934973
Creator: U.S. Food and Drug Administration
Published: 1994-01-28

Substantially Equivalent

Advanced Clinical Diagnostics

FDA 510(k) clearance K934973 for HELA-229/HELA CELLS, Substantially Equivalent on 1994-01-28. Applicant: Advanced Clinical Diagnostics. Device class: 1.

Clearance details

Applicant: Advanced Clinical Diagnostics
Product code: Code KIR
Device class: Class 1
Regulation: 21 CFR 864.2280
Advisory panel: Hematology
Date received: 1993-10-18
Decision date: 1994-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, US

Download summary PDF View on FDA.gov ↗

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