Cleared Traditional

RUBELISA (RUBESTAT)

K950227 · Bio-Whittaker, Inc., A Cambrex Co. · Microbiology

Aug 1995

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K950227 is an FDA 510(k) clearance for the RUBELISA (RUBESTAT), a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Bio-Whittaker, Inc., A Cambrex Co. (Walkersville, US). The FDA issued a Cleared decision on August 15, 1995, 217 days after receiving the submission on January 10, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number	K950227 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 1995
Decision Date	August 15, 1995
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF