The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Sensititre Auto Id Plate, Ap70.
| Device ID | K861058 |
| 510k Number | K861058 |
| Device Name: | SENSITITRE AUTO ID PLATE, AP70 |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 231 SUTTON STREET, NORTH Andover, MA 01845 |
| Contact | Frances Griggs |
| Correspondent | Frances Griggs GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 231 SUTTON STREET, NORTH Andover, MA 01845 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-19 |
| Decision Date | 1986-05-20 |