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
K864202Substantially Equivalent

Utiscreen(r) Bacterial Atp Test

Los Alamos Diagnostics, Los Alamos NM / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864202 is the FDA 510(k) clearance record for UTISCREEN(R) BACTERIAL ATP TEST, a class I device, cleared for Los Alamos Diagnostics on under FDA product code JXA (Kit, Screening, Urine). FDA records list 7 510(k) clearances for Los Alamos Diagnostics, from to . As of , FDA records show no recalls naming K864202.

Clearance record

Decision date
Received
(109 days to decision)
Product code
JXA Kit, Screening, Urine
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Los Alamos Diagnostics P.O. Box 1221, Los Alamos NM
Third party review
No

Clearances, product code JXA

Trailing 12 months

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

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