The following data is part of a premarket notification filed by Addent, Inc. with the FDA for Microlux/dl Microlux/blu Bio/screen.
| Device ID | K121282 |
| 510k Number | K121282 |
| Device Name: | MICROLUX/DL MICROLUX/BLU BIO/SCREEN |
| Classification | Diagnostic Light, Soft Tissue Detector |
| Applicant | ADDENT, INC. 43 MIRY BROOK RD. Danbury, CT 06810 |
| Contact | Joshua Friedman |
| Correspondent | Joshua Friedman ADDENT, INC. 43 MIRY BROOK RD. Danbury, CT 06810 |
| Product Code | NXV |
| CFR Regulation Number | 872.6350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-30 |
| Decision Date | 2012-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8691120010 | K121282 | 000 |