The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Cvm Transport, Model R96,viral Transport, Model R99, Cvm Transport Kit, Model R96 K, Viral Transport Kit, Model R99 K.
| Device ID | K993812 |
| 510k Number | K993812 |
| Device Name: | CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria, CA 93455 |
| Contact | Melissa M Taylor |
| Correspondent | Melissa M Taylor HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria, CA 93455 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-10 |
| Decision Date | 1999-12-21 |