510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823237Substantially Equivalent

Barbiturate Test Set #0550-050

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

K823237 is the FDA 510(k) clearance record for BARBITURATE TEST SET #0550-050, a class II device, cleared for Stanbio Laboratory on under FDA product code DJN (Mercury Dithiazone, Colorimetry, Barbiturate). FDA records list 47 510(k) clearances for Stanbio Laboratory, from to . As of , FDA records show no recalls naming K823237.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DJN Mercury Dithiazone, Colorimetry, Barbiturate
Regulation
21 CFR 862.3150
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Stanbio Laboratory 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DJN

Trailing 12 months

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

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