Product code MAM— Hematology
CD8 CYTOSPHERES KIT
- Classification name
- Dna-Probe, B And T Lymphocyte
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code MAM
FDA has cleared device under product code MAM, all in 1994, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code MAM
Recent clearances under product code MAM
Data sourced from openFDA. This site is unofficial and independent of the FDA.