510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834357Substantially Equivalent

Ana Trans Tube & Swabs Sterile Pack

Anaerobe Systems, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834357 is the FDA 510(k) clearance record for ANA TRANS TUBE & SWABS STERILE PACK, a class I device, cleared for Anaerobe Systems on under FDA product code JSL (Culture Media, Anaerobic Transport). FDA records list 52 510(k) clearances for Anaerobe Systems, from to . As of , FDA records show no recalls naming K834357.

Clearance record

Decision date
Received
(49 days to decision)
Product code
JSL Culture Media, Anaerobic Transport
Regulation
21 CFR 866.2390
Device class
Class I
Review panel
Microbiology
Applicant
Anaerobe Systems 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JSL

Trailing 12 months

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

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