510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092688Substantially Equivalent

Fora Poct S10/td-4258 Blood Glucose Monitoring System

Taidoc Technology Corporation, Taipei County, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092688 is the FDA 510(k) clearance record for FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM, a class II device, cleared for Taidoc Technology Corporation on under FDA product code LFR (Glucose Dehydrogenase, Glucose). FDA records list 123 510(k) clearances for Taidoc Technology Corporation, from to . As of , FDA records show no recalls naming K092688.

Clearance record

Decision date
Received
(673 days to decision)
Product code
LFR Glucose Dehydrogenase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Taidoc Technology Corporation 3f,5f, #127 Wugong 2nd Rd., Taipei County, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFR

Trailing 12 months

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

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