The following data is part of a premarket notification filed by Vai Diagnostics, Inc. with the FDA for Mccoy Cell Cultures.
| Device ID | K955608 |
| 510k Number | K955608 |
| Device Name: | MCCOY CELL CULTURES |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | VAI DIAGNOSTICS, INC. 5171 WILFONG RD. Memphis, TN 38134 |
| Contact | Robert F Naegele |
| Correspondent | Robert F Naegele VAI DIAGNOSTICS, INC. 5171 WILFONG RD. Memphis, TN 38134 |
| Product Code | KIR |
| CFR Regulation Number | 864.2280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-08 |
| Decision Date | 1996-07-08 |