510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K040958Substantially Equivalent

Prestige Models 24I and 400 and Mgc Model 240

Tokyo Boeki Medical System, Ltd., Raleigh NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040958 is the FDA 510(k) clearance record for PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240, a class I device, cleared for Tokyo Boeki Medical System , Ltd. on under FDA product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use). FDA records list one 510(k) clearance for Tokyo Boeki Medical System , Ltd. As of , FDA records show no recalls naming K040958.

Clearance record

Decision date
Received
(308 days to decision)
Product code
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Regulation
21 CFR 862.2160
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Tokyo Boeki Medical System , Ltd. 5304 Golden Moss Trl., Raleigh NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JJE

Trailing 12 months

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

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