FDA product code MLA: Dna Probe, Yeast
MLA is the FDA product code for dna probe, yeast. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under MLA. The average 510(k) review took 96 days (median 96). FDA has posted 2 recalls for MLA devices.
Classification
| Field | Value |
|---|---|
| Device name | Dna Probe, Yeast |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MLA clearance
Top MLA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Microprobe Corp. | 2 | 1993-06-18 |
Most recent MLA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931151 | Microprobe Corp. | AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA | 1993-06-18 | 102 |
| K931374 | Microprobe Corp. | AFFIRM VPIII MICROBIAL IDENTIFICATION TEST | 1993-06-15 | 89 |
Recalls for MLA devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-08-27.
Frequently asked questions
What is FDA product code MLA?
MLA is the FDA product code for dna probe, yeast. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is MLA?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MLA?
Across 2 cleared submissions the average was 96 days from receipt to decision (median 96).
Which companies have the most MLA clearances?
Microprobe Corp. (2).
Have MLA devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-08-27.
Next steps
- Run an FDA pathway report with predicate devices for product code MLA
- Run a recall and safety report across every MLA manufacturer
- Watch product code MLA 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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