FDA product code MCC: Dna-Probe, Haemophilus Spp.
MCC is the FDA product code for dna-probe, haemophilus spp.. It is a Class II device, regulated under 21 CFR 866.3300 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under MCC. The average 510(k) review took 81 days (median 81).
Classification
| Field | Value |
|---|---|
| Device name | Dna-Probe, Haemophilus Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3300 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MCC clearance
Top MCC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gen-Probe, Inc. | 2 | 1990-06-20 |
Most recent MCC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K901397 | Gen-Probe, Inc. | ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA. | 1990-06-20 | 86 |
| K897079 | Gen-Probe, Inc. | ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE | 1990-03-08 | 76 |
Recalls for MCC devices
openFDA lists no recalls for product code MCC.
Frequently asked questions
What is FDA product code MCC?
MCC is the FDA product code for dna-probe, haemophilus spp.. It is a Class II device, regulated under 21 CFR 866.3300 and reviewed by the Microbiology panel.
What device class is MCC?
Class II, regulation 21 CFR 866.3300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MCC?
Across 2 cleared submissions the average was 81 days from receipt to decision (median 81).
Which companies have the most MCC clearances?
Gen-Probe, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code MCC
- Run a recall and safety report across every MCC manufacturer
- Watch product code MCC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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