The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Quantex Ferritin.
| Device ID | K040879 |
| 510k Number | K040879 |
| Device Name: | QUANTEX FERRITIN |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | DBF |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-05 |
| Decision Date | 2004-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740057718 | K040879 | 000 |
| 00380740030094 | K040879 | 000 |
| 00380740156329 | K040879 | 000 |
| 00380740156275 | K040879 | 000 |