510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172412Substantially Equivalent

BacterioScan 216Dx System

Bacterioscan, Inc., Saint Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172412 is the FDA 510(k) clearance record for BacterioScan 216Dx System, a class I device, cleared for Bacterioscan, Inc. on under FDA product code QBQ (System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture). FDA's definition for product code QBQ reads: "Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium". FDA records list one 510(k) clearance for Bacterioscan, Inc. As of , FDA records show no recalls naming K172412.

Clearance record

Decision date
Received
(264 days to decision)
Product code
QBQ System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
Regulation
21 CFR 866.2560
Device class
Class I
Review panel
Microbiology
Applicant
Bacterioscan, Inc. 4041 Forest Park Ave., Saint Louis MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QBQ

Trailing 12 months

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

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