The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Modification To:roche Diagnostics Tina-quant Rheumatoid Factors Ii Test System.
| Device ID | K032535 |
| 510k Number | K032535 |
| Device Name: | MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Sherri L Coenen |
| Correspondent | Sherri L Coenen ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-18 |
| Decision Date | 2003-09-10 |
| Summary: | summary |