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 |