510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921495Substantially Equivalent

Dia Strips System, Modified

Symcon Intl., Inc., Lenexa KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921495 is the FDA 510(k) clearance record for DIA STRIPS SYSTEM, MODIFIED, a class II device, cleared for Symcon Intl., Inc. on under FDA product code JIO (Blood, Occult, Colorimetric, In Urine). FDA records list one 510(k) clearance for Symcon Intl., Inc. As of , FDA records show no recalls naming K921495.

Clearance record

Decision date
Received
(137 days to decision)
Product code
JIO Blood, Occult, Colorimetric, In Urine
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Symcon Intl., Inc. 8270 Nieman Rd., Lenexa KS
510(k) summary
Statement
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