The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Tina-quant Ferritin Gen. 4.
| Device ID | K100538 |
| 510k Number | K100538 |
| Device Name: | TINA-QUANT FERRITIN GEN. 4 |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Kathie J Goodwin |
| Correspondent | Kathie J Goodwin Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-25 |
| Decision Date | 2010-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121238 | K100538 | 000 |