510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771312Substantially Equivalent

Blood Urea Nitrogen (Bun) Reagent

Mallinckrodt Critical Care, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771312 is the FDA 510(k) clearance record for BLOOD UREA NITROGEN (BUN) REAGENT, a class II device, cleared for Mallinckrodt Critical Care on under FDA product code CDW (Diacetyl-Monoxime, Urea Nitrogen). FDA records list 92 510(k) clearances for Mallinckrodt Critical Care, from to . As of , FDA records show no recalls naming K771312.

Clearance record

Decision date
Received
(16 days to decision)
Product code
CDW Diacetyl-Monoxime, Urea Nitrogen
Regulation
21 CFR 862.1770
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Mallinckrodt Critical Care 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CDW

Trailing 12 months

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

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