510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K840719Substantially Equivalent

Bakteriette-VI-Pak

Great Lakes Intl., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840719 is the FDA 510(k) clearance record for BAKTERIETTE-VI-PAK, a class I device, cleared for Great Lakes Intl. on under FDA product code JTW (System, Transport, Aerobic). FDA records list one 510(k) clearance for Great Lakes Intl. As of , FDA records show no recalls naming K840719.

Clearance record

Decision date
Received
(47 days to decision)
Product code
JTW System, Transport, Aerobic
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Great Lakes Intl. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JTW

Trailing 12 months

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

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