510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971508Substantially Equivalent

Rhmk II Cell Culture, an Expanded Primary Rhesus Monkey Kidney Cell Culture

Bio-Whittaker, Inc., A Cambrex Co., Walkersville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971508 is the FDA 510(k) clearance record for RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE, a class I device, cleared for Bio-Whittaker, Inc., A Cambrex Co. on under FDA product code KIR (Cells, Animal And Human, Cultured). FDA records list 3 510(k) clearances for Bio-Whittaker, Inc., A Cambrex Co., from to . As of , FDA records show no recalls naming K971508.

Clearance record

Decision date
Received
(145 days to decision)
Product code
KIR Cells, Animal And Human, Cultured
Regulation
21 CFR 864.2280
Device class
Class I
Review panel
Hematology
Applicant
Bio-Whittaker, Inc., A Cambrex Co. 8830 Biggs Ford Rd., Walkersville MD
510(k) summary
Summary
Third party review
No

Clearances, product code KIR

Trailing 12 months

FDA records hold no clearances under product code KIR in the trailing twelve months.

FDA records show no clearances under product code KIR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KIR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260