The following data is part of a premarket notification filed by American Micro Scan with the FDA for Chlamydiae Flourescent Monoclonal Antibody Test.
| Device ID | K864389 |
| 510k Number | K864389 |
| Device Name: | CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| Applicant | AMERICAN MICRO SCAN 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | James Keller |
| Correspondent | James Keller AMERICAN MICRO SCAN 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Product Code | LJP |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-06 |
| Decision Date | 1986-12-04 |