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

Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum

21 CFR 866.3320 / Microbiology
FDA source (opens on fda.gov)

MIZ is the FDA product code for Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum, a class II device type, regulated under 21 CFR 866.3320. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MIZ
Device name
Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
Regulation
21 CFR 866.3320
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
2
Ingested recalls
0

Clearances, product code MIZ

By decision year
2 clearances under product code MIZ with a decision year between 1992 and 2011, 1992 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MIZ by decision year
YearClearances
19921
20111

Applicants with the most clearances

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

Companies listing this code with FDA

Companies whose registered establishments list this code