510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812986Substantially Equivalent

Agglutex Amphetamine Test Kit

Hoffmann-La Roche, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812986 is the FDA 510(k) clearance record for AGGLUTEX AMPHETAMINE TEST KIT, a class II device, cleared for Hoffmann-La Roche, Inc. on under FDA product code DJP (Radioimmunoassay, Amphetamine). FDA records list 49 510(k) clearances for Hoffmann-La Roche, Inc., from to . As of , FDA records show no recalls naming K812986.

Clearance record

Decision date
Received
(88 days to decision)
Product code
DJP Radioimmunoassay, Amphetamine
Regulation
21 CFR 862.3100
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Hoffmann-La Roche, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DJP

Trailing 12 months

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

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