Cleared Traditional

RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE

K971508 · Bio-Whittaker, Inc., A Cambrex Co. · Microbiology
Sep 1997
Decision
145d
Days
Class 1
Risk

About This 510(k) Submission

K971508 is an FDA 510(k) clearance for the RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE, a Cells, Animal And Human, Cultured (Class I — General Controls, product code KIR), submitted by Bio-Whittaker, Inc., A Cambrex Co. (Walkersville, US). The FDA issued a Cleared decision on September 17, 1997, 145 days after receiving the submission on April 25, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K971508 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1997
Decision Date September 17, 1997
Days to Decision 145 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code KIR — Cells, Animal And Human, Cultured
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2280