510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011400Substantially Equivalent

Mrsa-Screen

Denka Seiken'S, Tokyo, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011400 is the FDA 510(k) clearance record for MRSA-SCREEN, a class II device, cleared for Denka Seiken'S on under FDA product code MYI (System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies). FDA records list 4 510(k) clearances for Denka Seiken'S, from to . As of , FDA records show no recalls naming K011400.

Clearance record

Decision date
Received
(324 days to decision)
Product code
MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Denka Seiken'S 3-4-2 Nihonbashi, Tokyo, JP
510(k) summary
Summary
Third party review
No

Clearances, product code MYI

Trailing 12 months

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

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