The following data is part of a premarket notification filed by American Micro Scan with the FDA for Microdilution Panels.
| Device ID | K862140 |
| 510k Number | K862140 |
| Device Name: | MICRODILUTION PANELS |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AMERICAN MICRO SCAN 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Lorraine Weaver |
| Correspondent | Lorraine Weaver AMERICAN MICRO SCAN 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-04 |
| Decision Date | 1986-07-16 |