RUBELISA (RUBESTAT)— 510(k) K950227

Name: FDA 510(k) clearance K950227
Creator: U.S. Food and Drug Administration
Published: 1995-08-15

Substantially Equivalent

Bio-Whittaker, Inc., A Cambrex Co.

FDA 510(k) clearance K950227 for RUBELISA (RUBESTAT), Substantially Equivalent on 1995-08-15. Applicant: Bio-Whittaker, Inc., A Cambrex Co.. Device class: 2.

Clearance details

Applicant: Bio-Whittaker, Inc., A Cambrex Co.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1995-01-10
Decision date: 1995-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walkersville, MD, US

Download summary PDF View on FDA.gov ↗

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