510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863238Substantially Equivalent

Reads RF Test Kit for Igm Rheumatoid Factor

Biostar Medical Products, Inc., Arlington VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863238 is the FDA 510(k) clearance record for READS RF TEST KIT FOR IGM RHEUMATOID FACTOR, a class II device, cleared for Biostar Medical Products, Inc. on under FDA product code DHR (System, Test, Rheumatoid Factor). FDA records list 5 510(k) clearances for Biostar Medical Products, Inc., from to . As of , FDA records show no recalls naming K863238.

Clearance record

Decision date
Received
(48 days to decision)
Product code
DHR System, Test, Rheumatoid Factor
Regulation
21 CFR 866.5775
Device class
Class II
Review panel
Immunology
Applicant
Biostar Medical Products, Inc. Suite 1203 Crystal Plz. Bld.1, Arlington VA
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