The following data is part of a premarket notification filed by Viratest Intl., Inc. with the FDA for Mrc-5 Cell Culture Vial.
| Device ID | K952727 |
| 510k Number | K952727 |
| Device Name: | MRC-5 CELL CULTURE VIAL |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | VIRATEST INTL., INC. 7540 LOUIS PASTEUR, SUITE 205 San Antonio, TX 78229 |
| Contact | William J Northam |
| Correspondent | William J Northam VIRATEST INTL., INC. 7540 LOUIS PASTEUR, SUITE 205 San Antonio, TX 78229 |
| Product Code | KIR |
| CFR Regulation Number | 864.2280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-14 |
| Decision Date | 1995-11-20 |