The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Sensititire Ap60.
| Device ID | K811765 |
| 510k Number | K811765 |
| Device Name: | SENSITITIRE AP60 |
| Classification | Kit, Identification, Enterobacteriaceae |
| Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JSS |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-22 |
| Decision Date | 1981-08-13 |