The following data is part of a premarket notification filed by Ameritek Research Llc with the FDA for In-vitro Diagnostic Vaginitis Test Kit.
| Device ID | K050352 |
| 510k Number | K050352 |
| Device Name: | IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | AMERITEK RESEARCH LLC 15205 3RD DR. SE Mill Creek, WA 98012 |
| Contact | Kud Chaiang Yee |
| Correspondent | Kud Chaiang Yee AMERITEK RESEARCH LLC 15205 3RD DR. SE Mill Creek, WA 98012 |
| Product Code | JTO |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JMT |
| Subsequent Product Code | LJX |
| Subsequent Product Code | LNW |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-11 |
| Decision Date | 2005-09-01 |