510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103531Substantially Equivalent

Prestige 24I; Biolis 24I; Mgc 240

Tokyo Boeki Medisys, Inc., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103531 is the FDA 510(k) clearance record for PRESTIGE 24I; BIOLIS 24I; MGC 240, a class II device, cleared for Tokyo Boeki Medisys, Inc. on under FDA product code CFR (Hexokinase, Glucose). FDA records list 2 510(k) clearances for Tokyo Boeki Medisys, Inc., from to . As of , FDA records show no recalls naming K103531.

Clearance record

Decision date
Received
(365 days to decision)
Product code
CFR Hexokinase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Tokyo Boeki Medisys, Inc. 5105 Fairoaks Rd., Durham NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CFR

Trailing 12 months
1 clearance under product code CFR in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CFR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260