The following data is part of a premarket notification filed by American Micro Scan with the FDA for Pos Combo Panel.
Device ID | K844086 |
510k Number | K844086 |
Device Name: | POS COMBO PANEL |
Classification | Discs, Strips And Reagents, Microorganism Differentiation |
Applicant | AMERICAN MICRO SCAN 855 57TH. ST. SUITE G Sacramento, CA 95819 |
Contact | Alice J O'connell |
Correspondent | Alice J O'connell AMERICAN MICRO SCAN 855 57TH. ST. SUITE G Sacramento, CA 95819 |
Product Code | JTO |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-22 |
Decision Date | 1984-11-13 |