510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K113783Substantially Equivalent

Vitek 2 Ast- Gram Postive Penicillin for Streptococcus Pneumoniae

bioMerieux, Inc., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113783 is the FDA 510(k) clearance record for VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE, a class II device, cleared for bioMerieux, Inc. on under FDA product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation). FDA records list 408 510(k) clearances for bioMerieux, Inc., from to . As of , FDA records show no recalls naming K113783.

Clearance record

Decision date
Received
(229 days to decision)
Product code
LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Regulation
21 CFR 866.1645
Device class
Class II
Review panel
Microbiology
Applicant
bioMerieux, Inc. 100 Rodolphe St., Durham NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LON

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