510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111221Substantially Equivalent

Mission U500 Urine Analyzer

Acon Laboratories, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111221 is the FDA 510(k) clearance record for MISSION U500 URINE ANALYZER, a class II device, cleared for ACON Laboratories, Inc. on under FDA product code JIO (Blood, Occult, Colorimetric, In Urine). FDA records list 93 510(k) clearances for ACON Laboratories, Inc., from to . As of , FDA records show no recalls naming K111221.

Clearance record

Decision date
Received
(261 days to decision)
Product code
JIO Blood, Occult, Colorimetric, In Urine
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
ACON Laboratories, Inc. 10125 Mesa Rim Rd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JIO

Trailing 12 months

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

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