The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Tina-quant Complement C3c Test System.
| Device ID | K012361 |
| 510k Number | K012361 |
| Device Name: | TINA-QUANT COMPLEMENT C3C TEST SYSTEM |
| Classification | Complement C3, Antigen, Antiserum, Control |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Helen T Torney |
| Correspondent | Helen T Torney ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | CZW |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-25 |
| Decision Date | 2001-11-29 |
| Summary: | summary |