510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K895652Substantially Equivalent

Ebv-Ea Ifa Kit

Organon Teknika Treyburn, Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895652 is the FDA 510(k) clearance record for EBV-EA IFA KIT, a class I device, cleared for Organon Teknika Treyburn on under FDA product code LSE (Epstein-Barr Virus, Other). FDA records list one 510(k) clearance for Organon Teknika Treyburn. As of , FDA records show no recalls naming K895652.

Clearance record

Decision date
Received
(89 days to decision)
Product code
LSE Epstein-Barr Virus, Other
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
Organon Teknika Treyburn 100 Akzo Ave., Durham NC
Third party review
No

Clearances, product code LSE

Trailing 12 months
2 clearances under product code LSE in the twelve months to October 2026, October 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LSE, 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 20262