The following data is part of a premarket notification filed by Bard Diagnostic Sciences,inc. with the FDA for Bard Bta Trak Test.
| Device ID | K971402 |
| 510k Number | K971402 |
| Device Name: | BARD BTA TRAK TEST |
| Classification | System, Test, Tumor Marker, Monitoring, Bladder |
| Applicant | BARD DIAGNOSTIC SCIENCES,INC. 12277 134TH COURT, N.E. #100 Redmond, WA 98052 |
| Contact | Glen P Freiberg |
| Correspondent | Glen P Freiberg BARD DIAGNOSTIC SCIENCES,INC. 12277 134TH COURT, N.E. #100 Redmond, WA 98052 |
| Product Code | MMW |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-15 |
| Decision Date | 1998-04-15 |
| Summary: | summary |