510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972231Substantially Equivalent

Osom Mono Test 143

Wyntek Diagnostics, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972231 is the FDA 510(k) clearance record for OSOM MONO TEST 143, a class II device, cleared for Wyntek Diagnostics, Inc. on under FDA product code KTN (System, Test, Infectious Mononucleosis). FDA records list 12 510(k) clearances for Wyntek Diagnostics, Inc., from to . As of , FDA records show no recalls naming K972231.

Clearance record

Decision date
Received
(71 days to decision)
Product code
KTN System, Test, Infectious Mononucleosis
Regulation
21 CFR 866.5640
Device class
Class II
Review panel
Immunology
Applicant
Wyntek Diagnostics, Inc. 6146 Nancy Ridge Dr.,, San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code KTN

Trailing 12 months

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

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