The following data is part of a premarket notification filed by Scott Laboratories, Inc. with the FDA for Identicult-ae.
| Device ID | K852666 |
| 510k Number | K852666 |
| Device Name: | IDENTICULT-AE |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | SCOTT LABORATORIES, INC. Fiskeville, RI 02823 |
| Contact | Thomas W Kelley |
| Correspondent | Thomas W Kelley SCOTT LABORATORIES, INC. Fiskeville, RI 02823 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-24 |
| Decision Date | 1985-07-15 |