510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K896744Substantially Equivalent

Benzodiazepines/tricyclic Antidepressants by Hplc

Bio-Rad, Hercules CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896744 is the FDA 510(k) clearance record for BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC, a class II device, cleared for Bio-Rad on under FDA product code JXM (Enzyme Immunoassay, Benzodiazepine). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K896744.

Clearance record

Decision date
Received
(85 days to decision)
Product code
JXM Enzyme Immunoassay, Benzodiazepine
Regulation
21 CFR 862.3170
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Bio-Rad 4000 Alfred Nobel Dr., Hercules CA
Third party review
No

Clearances, product code JXM

Trailing 12 months

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

FDA records show no clearances under product code JXM in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JXM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260