The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Tina-quant Myoglobin Gen.2 Test System.
| Device ID | K061683 |
| 510k Number | K061683 |
| Device Name: | TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Theresa Ambrose Bush |
| Correspondent | Theresa Ambrose Bush ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-15 |
| Decision Date | 2006-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336147863 | K061683 | 000 |