The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Tina-quant Albumin Gen 2.
| Device ID | K101203 |
| 510k Number | K101203 |
| Device Name: | TINA-QUANT ALBUMIN GEN 2 |
| Classification | Albumin, Antigen, Antiserum, Control |
| Applicant | Roche Diagnostics 9115 HAGUE RD Indianapolis, IN 46250 |
| Contact | Kathie J Goodwin |
| Correspondent | Kathie J Goodwin Roche Diagnostics 9115 HAGUE RD Indianapolis, IN 46250 |
| Product Code | DCF |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-29 |
| Decision Date | 2010-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336120965 | K101203 | 000 |
| 04015630924899 | K101203 | 000 |