The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Medtec Autoblot 2000.
| Device ID | K951753 |
| 510k Number | K951753 |
| Device Name: | MEDTEC AUTOBLOT 2000 |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | MEDTEC, INC. COLUMBIA SQARE 555 THIRTEENTH STREET NW Washington, DC 20004 -1109 |
| Contact | Patricia B Shrader, Esq. |
| Correspondent | Patricia B Shrader, Esq. MEDTEC, INC. COLUMBIA SQARE 555 THIRTEENTH STREET NW Washington, DC 20004 -1109 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-17 |
| Decision Date | 1995-10-17 |