The following data is part of a premarket notification filed by Sensititre Ltd. with the FDA for Sensititre Stability Plates.
| Device ID | K880641 |
| 510k Number | K880641 |
| Device Name: | SENSITITRE STABILITY PLATES |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | SENSITITRE LTD. 8A INDUSTRIAL WAY #2 Salem, NH 03079 |
| Contact | Frances M Griggs |
| Correspondent | Frances M Griggs SENSITITRE LTD. 8A INDUSTRIAL WAY #2 Salem, NH 03079 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-11 |
| Decision Date | 1988-05-13 |