The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Polyvalent Fluorescent Antibody Reagents For Legio.
| Device ID | K854108 |
| 510k Number | K854108 |
| Device Name: | POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO |
| Classification | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Applicant | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 3351 WRIGHTSBORO RD. SUITE 502 Augusta, GA 30909 |
| Contact | David A Wall |
| Correspondent | David A Wall MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 3351 WRIGHTSBORO RD. SUITE 502 Augusta, GA 30909 |
| Product Code | LHL |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-08 |
| Decision Date | 1985-11-12 |