510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851099Substantially Equivalent

Igm Rheumatoid Factor Test Kit

Breit Laboratories, Inc., West Sacramento CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851099 is the FDA 510(k) clearance record for IGM RHEUMATOID FACTOR TEST KIT, a class II device, cleared for Breit Laboratories, Inc. on under FDA product code DHR (System, Test, Rheumatoid Factor). FDA records list 5 510(k) clearances for Breit Laboratories, Inc., from to . As of , FDA records show no recalls naming K851099.

Clearance record

Decision date
Received
(37 days to decision)
Product code
DHR System, Test, Rheumatoid Factor
Regulation
21 CFR 866.5775
Device class
Class II
Review panel
Immunology
Applicant
Breit Laboratories, Inc. 2510 Boatman Ave., West Sacramento CA
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