510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K862208Substantially Equivalent

King Diagnostics Uric Acid Test

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

K862208 is the FDA 510(k) clearance record for KING DIAGNOSTICS URIC ACID TEST, a class I device, cleared for King Diagnostics, Inc. on under FDA product code KNK (Acid, Uric, Uricase (Colorimetric)). FDA records list 41 510(k) clearances for King Diagnostics, Inc., from to . As of , FDA records show no recalls naming K862208.

Clearance record

Decision date
Received
(28 days to decision)
Product code
KNK Acid, Uric, Uricase (Colorimetric)
Regulation
21 CFR 862.1775
Device class
Class I
Review panel
Clinical Chemistry
Applicant
King Diagnostics, Inc. 6856 Hawthorn Park Dr., Indianapolis IN
Third party review
No

Clearances, product code KNK

Trailing 12 months

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

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