The following data is part of a premarket notification filed by American Micro Scan with the FDA for Anaerobe Rapid Chromogenic Id Panel.
| Device ID | K862332 |
| 510k Number | K862332 |
| Device Name: | ANAEROBE RAPID CHROMOGENIC ID PANEL |
| Classification | Kit, Anaerobic Identification |
| 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 | JSP |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-19 |
| Decision Date | 1986-08-27 |