510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922969Substantially Equivalent

King Diagnostics Urea Nitrogen Reagent

King Diagnostics, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922969 is the FDA 510(k) clearance record for KING DIAGNOSTICS UREA NITROGEN REAGENT, a class II device, cleared for King Diagnostics, Inc. on under FDA product code CDN (Urease, Photometric, Urea Nitrogen). FDA records list 41 510(k) clearances for King Diagnostics, Inc., from to . As of , FDA records show no recalls naming K922969.

Clearance record

Decision date
Received
(116 days to decision)
Product code
CDN Urease, Photometric, Urea Nitrogen
Regulation
21 CFR 862.1770
Device class
Class II
Review panel
Clinical Chemistry
Applicant
King Diagnostics, Inc. 6856 Hawthorn Park Dr., Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code CDN

Trailing 12 months

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

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