510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903505Substantially Equivalent

Bact/alert (Tm)

bioMerieux, Inc., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903505 is the FDA 510(k) clearance record for BACT/ALERT (TM), a class I device, cleared for Organon Teknika Corp. on under FDA product code MDB (System, Blood Culturing). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show 6 recalls naming K903505.

Clearance record

Decision date
Received
(221 days to decision)
Product code
MDB System, Blood Culturing
Regulation
21 CFR 866.2560
Device class
Class I
Review panel
Microbiology
Applicant
Organon Teknika Corp. 100 Akzo Ave., Durham NC
Third party review
No

Clearances, product code MDB

Trailing 12 months
1 clearance under product code MDB in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MDB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260