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

Cryptosporidium Spp.

21 CFR 866.3220 / Microbiology
FDA source (opens on fda.gov)

MHJ is the FDA product code for Cryptosporidium Spp., a class II device type, regulated under 21 CFR 866.3220. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MHJ
Device name
Cryptosporidium Spp.
Regulation
21 CFR 866.3220
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
15
Ingested recalls
1

Clearances, product code MHJ

By decision year
15 clearances under product code MHJ with a decision year between 1991 and 2017, 1996 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MHJ by decision year
YearClearances
19911
19921
19941
19963
19983
20032
20052
20131
20171

Applicants with the most clearances

Product code MHJ
Applicants holding the most 510(k) clearances under product code MHJ
ApplicantClearances
Techlab, Inc.5
Lmd Laboratories2
Alexon - Trend, Inc.1
Alexon Biomedical, Inc.1
Alexon, Inc.1
IVD Research, LLC.1
Meridian Diagnostics, Inc.1
Remel, Inc.1
Trend Scientific, Inc.1
Trinity Biotech, PLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order