The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Cvm Transport.
| Device ID | K955451 |
| 510k Number | K955451 |
| Device Name: | CVM TRANSPORT |
| 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 | 1995-11-29 |
| Decision Date | 1996-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819398023801 | K955451 | 000 |