Cleared Traditional

RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE (K971508) - FDA 510(k) Clearance

Class I Microbiology device.

K971508 · Bio-Whittaker, Inc., A Cambrex Co. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
145d
Days
Class 1
Risk

K971508 is an FDA 510(k) clearance for the RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Bio-Whittaker, Inc., A Cambrex Co. (Walkersville, US). The FDA issued a Cleared decision on September 17, 1997 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.2280 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio-Whittaker, Inc., A Cambrex Co. devices

Submission Details

510(k) Number K971508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 102d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIR Cells, Animal And Human, Cultured
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.