The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Legionella Pneumophila Ser. 1 Antigen Latex Test.
| Device ID | K864006 |
| 510k Number | K864006 |
| Device Name: | LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST |
| 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 | 1986-10-15 |
| Decision Date | 1987-04-20 |