510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960115Substantially Equivalent

Hichem Bun/urea Reagent Kit

Elan Pharma, Inc., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960115 is the FDA 510(k) clearance record for HICHEM BUN/UREA REAGENT KIT, a class II device, cleared for Elan Pharma, Inc. on under FDA product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen). FDA records list 4 510(k) clearances for Elan Pharma, Inc., from to . As of , FDA records show no recalls naming K960115.

Clearance record

Decision date
Received
(78 days to decision)
Product code
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Regulation
21 CFR 862.1770
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Elan Pharma, Inc. 231 N. Puente St., Brea CA
510(k) summary
Summary
Third party review
No

Clearances, product code CDQ

Trailing 12 months

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

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