The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Sensititre Susceptibility Plates.
| Device ID | K860753 |
| 510k Number | K860753 |
| Device Name: | SENSITITRE SUSCEPTIBILITY PLATES |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 231 SUTTON STREET, NORTH Andover, MA 01845 |
| Contact | Frances M Griggs |
| Correspondent | Frances M Griggs GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 231 SUTTON STREET, NORTH Andover, MA 01845 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-27 |
| Decision Date | 1986-05-06 |