510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K920753Substantially Equivalent

RF Stat Igm Test Kit

Biowhittaker Molecular Applications, Inc., Walkersville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920753 is the FDA 510(k) clearance record for RF STAT IGM TEST KIT, a class II device, cleared for Biowhittaker Molecular Applications, Inc. on under FDA product code DHR (System, Test, Rheumatoid Factor). FDA records list 10 510(k) clearances for Biowhittaker Molecular Applications, Inc., from to . As of , FDA records show no recalls naming K920753.

Clearance record

Decision date
Received
(40 days to decision)
Product code
DHR System, Test, Rheumatoid Factor
Regulation
21 CFR 866.5775
Device class
Class II
Review panel
Immunology
Applicant
Biowhittaker Molecular Applications, Inc. 8830 Biggs Ford Rd., Walkersville MD
510(k) summary
Statement
Third party review
No

Clearances, product code DHR

Trailing 12 months

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

FDA records show no clearances under product code DHR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DHR, 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