In-Vitro Diagnostic Vaginitis Test Kit
FDA 510(k) K050352 · Ameritek Research, LLC
510(k) numberK050352
Submission
- Device name
- In-Vitro Diagnostic Vaginitis Test Kit
- Applicant
- Ameritek Research, LLC
Mill Creek, WA, US - Received
- February 11, 2005
- Decision date
- September 1, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JTO – Discs, Strips And Reagents, Microorganism Differentiation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JTO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970832 | Pyr SwabJTO · Traditional | Remel, Inc. | 04/24/1997SE |
| K970834 | Gram SwabJTO · Traditional | Remel, Inc. | 04/17/1997SE |
| K970833 | Indole SwabJTO · Traditional | Remel, Inc. | 04/02/1997SE |
| K970009 | Lyfo(Tm) Differential Disk-BacitracinJTO · Traditional | Microbiologics, Inc. | 02/06/1997SE |
| K962966 | Ids Rapid CB Plus SystemJTO · Traditional | Innovative Diagnostic Systems, Inc. | 10/08/1996SE |
| K961191 | ColiscreenJTO · Traditional | Hardy Diagnostics | 06/17/1996SE |
| K960996 | M. Cat Butyrate DiskJTO · Traditional | Hardy Diagnostics | 04/18/1996SE |
| K955826 | Gibson Id-M. Cat.JTO · Traditional | Gibson Laboratories, Inc. | 02/29/1996SE |
| K954783 | Dryslide CartarrhalisJTO · Traditional | Difco Laboratories, Inc. | 02/06/1996SE |
| K954812 | Lyfo(Tm) Differiental Disk-PyrJTO · Traditional | Microbiologics, Inc. | 12/20/1995SE |
Questions and answers
When was In-Vitro Diagnostic Vaginitis Test Kit cleared by the FDA?
In-Vitro Diagnostic Vaginitis Test Kit (K050352) received a 510(k) decision of Substantially Equivalent on September 1, 2005, 202 days after the submission was received.
What is the product code of K050352?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.