The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Modification To Profile -ii.
| Device ID | K002776 |
| 510k Number | K002776 |
| Device Name: | MODIFICATION TO PROFILE -II |
| Classification | Enzyme Immunoassay, Phencyclidine |
| Applicant | MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Contact | Michael Turanchik |
| Correspondent | Michael Turanchik MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Product Code | LCM |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKE |
| Subsequent Product Code | DKZ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-06 |
| Decision Date | 2000-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690286000346 | K002776 | 000 |