The following data is part of a premarket notification filed by Scantibodies Laboratory, Inc. with the FDA for Syscon Turmor Marker Control.
| Device ID | K955812 |
| 510k Number | K955812 |
| Device Name: | SYSCON TURMOR MARKER CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | SCANTIBODIES LABORATORY, INC. 9251 S.W. 52ND TERRACE Miami, FL 33165 |
| Contact | Rosetta Geffen |
| Correspondent | Rosetta Geffen SCANTIBODIES LABORATORY, INC. 9251 S.W. 52ND TERRACE Miami, FL 33165 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-26 |
| Decision Date | 1996-03-12 |
| Summary: | summary |