510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K875259Substantially Equivalent

Bitek(tm) Blood Culture System

Definitive Diagnostics, Inc., Tualatin OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875259 is the FDA 510(k) clearance record for BITEK(TM) BLOOD CULTURE SYSTEM, a class I device, cleared for Definitive Diagnostics, Inc. on under FDA product code JSG (Culture Media, Non-Selective And Non-Differential). FDA records list 2 510(k) clearances for Definitive Diagnostics, Inc., from to . As of , FDA records show no recalls naming K875259.

Clearance record

Decision date
Received
(36 days to decision)
Product code
JSG Culture Media, Non-Selective And Non-Differential
Regulation
21 CFR 866.2300
Device class
Class I
Review panel
Microbiology
Applicant
Definitive Diagnostics, Inc. P.O. Box 578, Tualatin OR
Third party review
No

Clearances, product code JSG

Trailing 12 months

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

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