The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Diagnostics Tina-quant Igm Gen.2.
| Device ID | K040431 |
| 510k Number | K040431 |
| Device Name: | ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 |
| Classification | Igm (mu Chain Specific), Antigen, Antiserum, Control |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Sherri L Coenen |
| Correspondent | Sherri L Coenen ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | DAO |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-19 |
| Decision Date | 2004-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121337 | K040431 | 000 |