The following data is part of a premarket notification filed by Bard Diagnostic Sciences,inc. with the FDA for Bta Stat Test Prescription Home Use.
| Device ID | K974845 |
| 510k Number | K974845 |
| Device Name: | BTA STAT TEST PRESCRIPTION HOME USE |
| Classification | System, Test, Tumor Marker, Monitoring, Bladder |
| Applicant | BARD DIAGNOSTIC SCIENCES,INC. 12277 134TH COURT, N.E. #100 Redmond, WA 98052 |
| Contact | Glen Paul Freiberg |
| Correspondent | Glen Paul 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 | 1997-12-18 |
| Decision Date | 1998-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855574005636 | K974845 | 000 |
| 00855574005629 | K974845 | 000 |
| 00855574005353 | K974845 | 000 |
| 00855574005278 | K974845 | 000 |
| 00855574005261 | K974845 | 000 |
| 00855574005001 | K974845 | 000 |
| 10743816001409 | K974845 | 000 |
| 10743816001393 | K974845 | 000 |