510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K851250Substantially Equivalent

Septi-Chek Tsb W/sucrose Blood Culture Bottle-Roch

Roche Diagnostic Systems, Inc., Nutley NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851250 is the FDA 510(k) clearance record for SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH, a class I device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code JSG (Culture Media, Non-Selective And Non-Differential). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K851250.

Clearance record

Decision date
Received
(26 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
Roche Diagnostic Systems, Inc. Div. Of Hoffmann-La Roche, Inc, Nutley NJ
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