510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840503Substantially Equivalent

Sdl Listeria Monocytogenes Control

Scientific Device Laboratory, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840503 is the FDA 510(k) clearance record for SDL LISTERIA MONOCYTOGENES CONTROL, a class I device, cleared for Scientific Device Laboratory, Inc. on under FDA product code GSI (Antigens, Slide And Tube, All Types, Listeria Monocytogenes). FDA records list 28 510(k) clearances for Scientific Device Laboratory, Inc., from to . As of , FDA records show no recalls naming K840503.

Clearance record

Decision date
Received
(46 days to decision)
Product code
GSI Antigens, Slide And Tube, All Types, Listeria Monocytogenes
Regulation
21 CFR 866.3355
Device class
Class I
Review panel
Microbiology
Applicant
Scientific Device Laboratory, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GSI

Trailing 12 months

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

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