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
K893124Substantially Equivalent

Olympus Pk(tm) Tp

Fujirebio Diagnostics, Inc., North Caldwell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893124 is the FDA 510(k) clearance record for OLYMPUS PK(TM) TP, a class II device, cleared for Fujirebio Diagnostics,Inc. on under FDA product code GMT (Antigens, Ha, Treponema Pallidum). FDA records list 45 510(k) clearances for Fujirebio Diagnostics,Inc., from to . As of , FDA records show no recalls naming K893124.

Clearance record

Decision date
Received
(206 days to decision)
Product code
GMT Antigens, Ha, Treponema Pallidum
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Applicant
Fujirebio Diagnostics,Inc. Schiff & Company, North Caldwell NJ
Third party review
No

Clearances, product code GMT

Trailing 12 months

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

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