The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Tina-quant Soluble Transferrin Receptor Test System, Hitachi Catalog # 2148315; Integra Catalog # 2148323.
| Device ID | K003064 |
| 510k Number | K003064 |
| Device Name: | TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 |
| Classification | Transferrin, Antigen, Antiserum, Control |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | DDG |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-02 |
| Decision Date | 2001-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336147924 | K003064 | 000 |
| 04015630919444 | K003064 | 000 |
| 04015630928750 | K003064 | 000 |
| 04015630919482 | K003064 | 000 |
| 04015630918614 | K003064 | 000 |
| 04015630914395 | K003064 | 000 |