The following data is part of a premarket notification filed by Dynagen, Inc. with the FDA for Procheck(tm) Blind Performance Specimens.
| Device ID | K931105 |
| 510k Number | K931105 |
| Device Name: | PROCHECK(TM) BLIND PERFORMANCE SPECIMENS |
| Classification | Drug Mixture Control Materials |
| Applicant | DYNAGEN, INC. 99 ERIE ST. Cambridge, MA 02139 |
| Contact | Peter J Mione |
| Correspondent | Peter J Mione DYNAGEN, INC. 99 ERIE ST. Cambridge, MA 02139 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-03 |
| Decision Date | 1993-04-21 |