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
K881259Substantially Equivalent

Mak-6 Monoclonal Anti-Cytokeratin Cocktail

Triton Biosciences, Inc., Alameda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881259 is the FDA 510(k) clearance record for MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL, a class II device, cleared for Triton Biosciences, Inc. on under FDA product code LYE (Cytokeratins). FDA records list one 510(k) clearance for Triton Biosciences, Inc. As of , FDA records show no recalls naming K881259.

Clearance record

Decision date
Received
(203 days to decision)
Product code
LYE Cytokeratins
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Applicant
Triton Biosciences, Inc. 1501 Harbor Bay Pkwy., Alameda CA
Third party review
No

Clearances, product code LYE

Trailing 12 months

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

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