Aura Tek FDP
FDA 510(k) K970353 · Perimmune, Inc.
510(k) numberK970353
Submission
- Device name
- Aura Tek FDP
- Applicant
- Perimmune, Inc.
Rockville, MD, US - Received
- January 30, 1997
- Decision date
- April 30, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MMW – System, Test, Tumor Marker, Monitoring, Bladder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
Other 510(k)s with product code MMW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203245 | Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit…MMW · Traditional | Nucleix , Ltd. | 05/04/2023SE |
| K033982 | Modification to Vysis Urovysion Bladder Cancer Recurrence TestMMW · Special | Vysis | 01/22/2004SE |
| K021231 | NMP22 Bladderchek Kit, NMP22 Control KitMMW · Traditional | Matritech, Inc. | 07/30/2002SE |
| K013785 | Urovysion Bladder Cancer Recurrence KitMMW · Abbreviated | Vysis | 02/08/2002SE |
| K011031 | Vysis Urovysion Bladder Cancer Recurrence KitMMW · Traditional | Vysis | 08/03/2001SE |
| K974845 | Bta Stat Test Prescription Home UseMMW · Traditional | Bard Diagnostic Sciences,Inc. | 12/08/1998SE |
| K971402 | Bard Bta Trak TestMMW · Traditional | Bard Diagnostic Sciences,Inc. | 04/15/1998SE |
| K964151 | Bard and Bta TestMMW · Traditional | Bard Diagnostic Sciences,Inc. | 04/16/1997SE |
More from Bard Diagnostic Sciences,Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970302 | Apo-Tek Lp(A)DFC · Traditional | 11/10/1997SE |
Questions and answers
When was Aura Tek FDP cleared by the FDA?
Aura Tek FDP (K970353) received a 510(k) decision of Substantially Equivalent on April 30, 1997, 90 days after the submission was received.
What is the product code of K970353?
The FDA product code is MMW – System, Test, Tumor Marker, Monitoring, Bladder, a Class II (moderate risk) device regulated under 21 CFR 866.6010.