The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Sensititre Indole Reagent.
| Device ID | K894776 |
| 510k Number | K894776 |
| Device Name: | SENSITITRE INDOLE REAGENT |
| Classification | Kit, Identification, Enterobacteriaceae |
| Applicant | RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Gerald L Vedaa |
| Correspondent | Gerald L Vedaa RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | JSS |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-27 |
| Decision Date | 1989-08-31 |