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
K874259Substantially Equivalent

Trichomonas Direct Enzyme Immunoassay

California Integrated Diagnostics, Inc., Berkeley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874259 is the FDA 510(k) clearance record for TRICHOMONAS DIRECT ENZYME IMMUNOASSAY, a class I device, cleared for California Integrated Diagnostics, Inc. on under FDA product code JWZ (Kit, Screening, Trichomonas). FDA records list 4 510(k) clearances for California Integrated Diagnostics, Inc., from to . As of , FDA records show no recalls naming K874259.

Clearance record

Decision date
Received
(48 days to decision)
Product code
JWZ Kit, Screening, Trichomonas
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
California Integrated Diagnostics, Inc. 1440 Fourth St., Berkeley CA
Third party review
No

Clearances, product code JWZ

Trailing 12 months

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

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