510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023297Substantially Equivalent

Urs-1B (Blood Test)

Teco Diagnostics, Anaheim CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K023297 is the FDA 510(k) clearance record for URS-1B (BLOOD TEST), a class II device, cleared for Teco Diagnostics on under FDA product code JIO (Blood, Occult, Colorimetric, In Urine). FDA records list 55 510(k) clearances for Teco Diagnostics, from to . As of , FDA records show no recalls naming K023297.

Clearance record

Decision date
Received
(155 days to decision)
Product code
JIO Blood, Occult, Colorimetric, In Urine
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Teco Diagnostics 1268 . Lakeview Ave., Anaheim CA
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