The following data is part of a premarket notification filed by American Micro Scan with the FDA for Gram Positive Fluorescent Identification Panel.
| Device ID | K863038 |
| 510k Number | K863038 |
| Device Name: | GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL |
| Classification | Gram Positive Identification Panel |
| 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 | LQL |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-12 |
| Decision Date | 1986-09-30 |