FDA product code MAM: Dna-Probe, B And T Lymphocyte
MAM is the FDA product code for dna-probe, b and t lymphocyte. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under MAM. The average 510(k) review took 627 days (median 627). 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Dna-Probe, B And T Lymphocyte |
| Device class | Class II |
| Regulation | 21 CFR 864.5220 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MAM clearance
Top MAM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coulter Electronics, Inc. | 1 | 1994-04-25 |
Most recent MAM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923951 | Coulter Electronics, Inc. | CD8 CYTOSPHERES KIT | 1994-04-25 | 627 |
Recalls for MAM devices
openFDA lists no recalls for product code MAM.
Frequently asked questions
What is FDA product code MAM?
MAM is the FDA product code for dna-probe, b and t lymphocyte. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Hematology panel.
What device class is MAM?
Class II, regulation 21 CFR 864.5220. Typical premarket route: 510(k).
How long does a 510(k) take for product code MAM?
Across 1 cleared submissions the average was 627 days from receipt to decision (median 627).
Which companies have the most MAM clearances?
Coulter Electronics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MAM
- Run a recall and safety report across every MAM manufacturer
- Watch product code MAM 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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