510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812732Substantially Equivalent

Septi-Chek Bh1 Blood Culture Bottle

Hoffmann-La Roche, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812732 is the FDA 510(k) clearance record for SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE, a class I device, cleared for Hoffmann-La Roche, Inc. on under FDA product code JSG (Culture Media, Non-Selective And Non-Differential). FDA records list 49 510(k) clearances for Hoffmann-La Roche, Inc., from to . As of , FDA records show no recalls naming K812732.

Clearance record

Decision date
Received
(21 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
Hoffmann-La Roche, Inc. 803 N. Front St. Suite 3, Mchenry IL
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