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

Enzyme Linked Immunosorbent Assay, Coccidioides Immitis

21 CFR 866.3135 / Microbiology
FDA source (opens on fda.gov)

MIY is the FDA product code for Enzyme Linked Immunosorbent Assay, Coccidioides Immitis, a class II device type, regulated under 21 CFR 866.3135. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
MIY
Device name
Enzyme Linked Immunosorbent Assay, Coccidioides Immitis
Regulation
21 CFR 866.3135
Device class
Class II
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code MIY

By decision year
1 clearance under product code MIY with a decision year between 1992 and 1992, 1992 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MIY by decision year
YearClearances
19921

Applicants with the most clearances

Product code MIY
Applicants holding the most 510(k) clearances under product code MIY
ApplicantClearances
Meridian Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code