The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Sensi-cal Amco Aepa-1.
| Device ID | K935566 |
| 510k Number | K935566 |
| Device Name: | SENSI-CAL AMCO AEPA-1 |
| Classification | Reagent/device, Inoculum Calibration |
| Applicant | RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Jennifer Lorbach |
| Correspondent | Jennifer Lorbach RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | LIE |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1994-03-29 |