510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K871115Substantially Equivalent

Ub Analyzer, Model Ua-1/Reagent Kit/bilirubin Con.

Labo Science-USA, Inc., Briarcliff Manor NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871115 is the FDA 510(k) clearance record for UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON., a class II device, cleared for Labo Science-USA, Inc. on under FDA product code CIG (Diazo Colorimetry, Bilirubin). FDA records list one 510(k) clearance for Labo Science-USA, Inc. As of , FDA records show no recalls naming K871115.

Clearance record

Decision date
Received
(680 days to decision)
Product code
CIG Diazo Colorimetry, Bilirubin
Regulation
21 CFR 862.1110
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Labo Science-USA, Inc. 8 Sloehiddon Rd., Briarcliff Manor NY
Third party review
No

Clearances, product code CIG

Trailing 12 months
1 clearance under product code CIG in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CIG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260