BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.— 510(k) K934242

Name: FDA 510(k) clearance K934242
Creator: U.S. Food and Drug Administration
Published: 1994-01-03

Substantially Equivalent

Advanced Clinical Diagnostics

FDA 510(k) clearance K934242 for BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K., Substantially Equivalent on 1994-01-03. 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: 1993-08-26
Decision date: 1994-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, US

Download summary PDF View on FDA.gov ↗

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