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

Enzyme Linked Immunosorbent Assay, T. Cruzi

21 CFR 866.3870 / Microbiology
FDA source (opens on fda.gov)

MIU is the FDA product code for Enzyme Linked Immunosorbent Assay, T. Cruzi, a class I device type, regulated under 21 CFR 866.3870. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MIU
Device name
Enzyme Linked Immunosorbent Assay, T. Cruzi
Regulation
21 CFR 866.3870
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
1

Clearances, product code MIU

By decision year
6 clearances under product code MIU with a decision year between 1992 and 2016, 1992 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MIU by decision year
YearClearances
19921
19941
19951
20041
20091
20161

Applicants with the most clearances

Product code MIU
Applicants holding the most 510(k) clearances under product code MIU
ApplicantClearances
Abbott Medical1
Gull Laboratories, Inc.1
Hemagen Diagnostics, Inc.1
Inbios International, Inc.1
Ortho-Clinical Diagnostics, Inc.1
Wiener Laboratories Saic1

Companies listing this code with FDA

Companies whose registered establishments list this code