The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Borrelia Burgdorferi Polyval Igg/igm Antibody Test.
| Device ID | K911145 |
| 510k Number | K911145 |
| Device Name: | BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST |
| Classification | Reagent, Borrelia Serological Reagent |
| 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 | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-01 |
| Decision Date | 1991-05-10 |