The following data is part of a premarket notification filed by Seracare Technology with the FDA for Qualitrol Tumor Marker Control, Levels 1 And 2.
| Device ID | K993631 |
| 510k Number | K993631 |
| Device Name: | QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | SERACARE TECHNOLOGY 2170 WOODWARD ST. Austin, TX 78744 -1832 |
| Contact | Rusty Sewell |
| Correspondent | Rusty Sewell SERACARE TECHNOLOGY 2170 WOODWARD ST. Austin, TX 78744 -1832 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-27 |
| Decision Date | 1999-12-09 |