510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K931922Substantially Equivalent

Diadot(tm) Virus/chlamydia Transport

Viratest Intl., Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931922 is the FDA 510(k) clearance record for DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT, a class I device, cleared for Viratest Intl., Inc. on under FDA product code JSM (Culture Media, Non-Propagating Transport). FDA records list 3 510(k) clearances for Viratest Intl., Inc., from to . As of , FDA records show no recalls naming K931922.

Clearance record

Decision date
Received
(348 days to decision)
Product code
JSM Culture Media, Non-Propagating Transport
Regulation
21 CFR 866.2390
Device class
Class I
Review panel
Microbiology
Applicant
Viratest Intl., Inc. 7540 Louis Pasteur, Suite 205, San Antonio TX
510(k) summary
Summary
Third party review
No

Clearances, product code JSM

Trailing 12 months
1 clearance under product code JSM in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JSM, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260