The following data is part of a premarket notification filed by Viratest Intl., Inc. with the FDA for Diadot(tm) Virus/chlamydia Transport.
| Device ID | K931922 |
| 510k Number | K931922 |
| Device Name: | DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | VIRATEST INTL., INC. 7540 LOUIS PASTEUR, SUITE 205 San Antonio, TX 78229 |
| Contact | Kalter |
| Correspondent | Kalter VIRATEST INTL., INC. 7540 LOUIS PASTEUR, SUITE 205 San Antonio, TX 78229 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-16 |
| Decision Date | 1994-03-30 |