510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890689Substantially Equivalent

Adx Tm Opiates

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890689 is the FDA 510(k) clearance record for ADX TM OPIATES, a class I device, cleared for Abbott Laboratories on under FDA product code DGJ (Colostrum, Antigen, Antiserum, Control). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K890689.

Clearance record

Decision date
Received
(192 days to decision)
Product code
DGJ Colostrum, Antigen, Antiserum, Control
Regulation
21 CFR 866.5230
Device class
Class I
Review panel
Immunology
Applicant
Abbott Laboratories One Abbott Park Rd., Abbott Park IL
Third party review
No

Clearances, product code DGJ

Trailing 12 months

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

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