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
K900455Substantially Equivalent

Zefazone Susceptibility Powder

The Upjohn Co., Kalamazoo MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900455 is the FDA 510(k) clearance record for ZEFAZONE SUSCEPTIBILITY POWDER, a class II device, cleared for The Upjohn Co. on under FDA product code LOP (Solution, Antimicrobial). FDA records list 6 510(k) clearances for The Upjohn Co., from to . As of , FDA records show no recalls naming K900455.

Clearance record

Decision date
Received
(10 days to decision)
Product code
LOP Solution, Antimicrobial
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
The Upjohn Co. 7000 Portage Rd., Kalamazoo MI
Third party review
No

Clearances, product code LOP

Trailing 12 months

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

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