The following data is part of a premarket notification filed by American Micro Scan with the FDA for Neg Combo Breakpoint Panel Pos Combo.
Device ID | K854278 |
510k Number | K854278 |
Device Name: | NEG COMBO BREAKPOINT PANEL POS COMBO |
Classification | Kit, Screening, Staphylococcus Aureus |
Applicant | AMERICAN MICRO SCAN 855 57TH. ST. SUITE G Sacramento, CA 95819 |
Contact | Krista L Underwood |
Correspondent | Krista L Underwood AMERICAN MICRO SCAN 855 57TH. ST. SUITE G Sacramento, CA 95819 |
Product Code | JWX |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-10-24 |
Decision Date | 1986-03-04 |