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

System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

21 CFR 866.1640 / Microbiology
FDA source (opens on fda.gov)

MYI is the FDA product code for System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies, a class II device type, regulated under 21 CFR 866.1640. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MYI
Device name
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
10
Ingested recalls
0

Clearances, product code MYI

By decision year
10 clearances under product code MYI with a decision year between 1999 and 2014, 2002 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MYI by decision year
YearClearances
19991
20011
20022
20061
20102
20121
20142

Applicants with the most clearances

Product code MYI
Applicants holding the most 510(k) clearances under product code MYI
ApplicantClearances
Alere Scarborough, Inc.2
Binax, Inc.2
Id Biomedical Corp.2
Advandx, Inc.1
Denka Seiken'S1
Mast Group Ltd.1
Oxoid, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code