510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K890957Substantially Equivalent

Hycor Sentry Drugs of Abuse Urine Control:

Hycor Biomedical, Garden Grove CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890957 is the FDA 510(k) clearance record for HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:, a class I device, cleared for Hycor Biomedical, Inc. on under FDA product code DIF (Drug Mixture Control Materials). FDA records list 66 510(k) clearances for Hycor Biomedical, Inc., from to . As of , FDA records show no recalls naming K890957.

Clearance record

Decision date
Received
(10 days to decision)
Product code
DIF Drug Mixture Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Hycor Biomedical, Inc. 7272 Chapman Ave., Garden Grove CA
Third party review
No

Clearances, product code DIF

Trailing 12 months

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

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