510(k) K970353
- Device
- AURA TEK FDP
- Applicant
- PERIMMUNE, INC.
- 510(k) number
- K970353
- Product code
- MMW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-30
- Date received
- 1997-01-30
- Regulation
- 866.6010
- Classification name
- System, Test, Tumor Marker, Monitoring, Bladder
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHERYL RUPPEL
- Address
- 1330 Piccard Dr. Rockville MD US 20850 20850
FDA Registration Numbers#
- 1221359
- 3012885391
- 3004530258
- 3016838963
- 2435505
Source Documents#
Other 510(k) Records For Product Code MMW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203245 | Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C | Nucleix , Ltd. | 2023-05-04 |
| K033982 | MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST | Vysis | 2004-01-22 |
| K021231 | NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT | Matritech, Inc. | 2002-07-30 |
| K013785 | UROVYSION BLADDER CANCER RECURRENCE KIT | Vysis | 2002-02-08 |
| K011031 | VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT | Vysis | 2001-08-03 |
| K974845 | BTA STAT TEST PRESCRIPTION HOME USE | Bard Diagnostic Sciences,Inc. | 1998-12-08 |
| K971402 | BARD BTA TRAK TEST | Bard Diagnostic Sciences,Inc. | 1998-04-15 |
| K964151 | BARD AND BTA TEST | Bard Diagnostic Sciences,Inc. | 1997-04-16 |
Legacy Summary#
summary
FDA Review#
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