The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Cytomegalovirus Control Slides.
Device ID | K873114 |
510k Number | K873114 |
Device Name: | CYTOMEGALOVIRUS CONTROL SLIDES |
Classification | Antigen, Cf (including Cf Control), Cytomegalovirus |
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 | GQH |
CFR Regulation Number | 866.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-10 |
Decision Date | 1987-09-25 |