510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020595Substantially Equivalent

Xenostrip-Tv Trichomonas Cassette Test, Model C1383.01

Xenotope Diagnostics, Inc., Northridge CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K020595 is the FDA 510(k) clearance record for XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01, a class I device, cleared for Xenotope Diagnostics, Inc. on under FDA product code JWZ (Kit, Screening, Trichomonas). FDA records list one 510(k) clearance for Xenotope Diagnostics, Inc. As of , FDA records show no recalls naming K020595.

Clearance record

Decision date
Received
(363 days to decision)
Product code
JWZ Kit, Screening, Trichomonas
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Xenotope Diagnostics, Inc. 9418 Lasaine Ave., Northridge CA
510(k) summary
Statement
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