510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883327Substantially Equivalent

Clinistat Bun (Blood Urea Nitrogen) Reagent Test

Kulzer GmbH, Elkhart IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883327 is the FDA 510(k) clearance record for CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST, a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code JGZ (O-Phthalaldehyde, Urea Nitrogen). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K883327.

Clearance record

Decision date
Received
(168 days to decision)
Product code
JGZ O-Phthalaldehyde, Urea Nitrogen
Regulation
21 CFR 862.1770
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Heraeus Kulzer, Inc. Diagnostics Division, Elkhart IN
Third party review
No

Clearances, product code JGZ

Trailing 12 months

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

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