510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K781816Substantially Equivalent

Inoculator, Aim-4 Microprocessor

Axford Manufacturing, Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781816 is the FDA 510(k) clearance record for INOCULATOR, AIM-4 MICROPROCESSOR, a class I device, cleared for Axford Manufacturing , Ltd. on under FDA product code JSS (Kit, Identification, Enterobacteriaceae). FDA records list one 510(k) clearance for Axford Manufacturing , Ltd. As of , FDA records show no recalls naming K781816.

Clearance record

Decision date
Received
(41 days to decision)
Product code
JSS Kit, Identification, Enterobacteriaceae
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Axford Manufacturing , Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JSS

Trailing 12 months

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

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