The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Tina-quant Igg Gen.2.
| Device ID | K050113 |
| 510k Number | K050113 |
| Device Name: | TINA-QUANT IGG GEN.2 |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Theresa M Ambrose |
| Correspondent | Theresa M Ambrose ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-18 |
| Decision Date | 2005-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121320 | K050113 | 000 |