510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812985Substantially Equivalent

Agglutex Morphine Test Kit

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

K812985 is the FDA 510(k) clearance record for AGGLUTEX MORPHINE TEST KIT, a class I device, cleared for Hoffmann-La Roche, Inc. on under FDA product code DDF (Prothrombin, Antigen, Antiserum, Control). FDA records list 49 510(k) clearances for Hoffmann-La Roche, Inc., from to . As of , FDA records show no recalls naming K812985.

Clearance record

Decision date
Received
(66 days to decision)
Product code
DDF Prothrombin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5735
Device class
Class I
Review panel
Immunology
Applicant
Hoffmann-La Roche, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DDF

Trailing 12 months

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

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