The following data is part of a premarket notification filed by Scantibodies Laboratory, Inc. with the FDA for Syscos Idc - G, Idc, Bsc, Idc - G.
| Device ID | K974262 |
| 510k Number | K974262 |
| Device Name: | SYSCOS IDC - G, IDC, BSC, IDC - G |
| Classification | Kit, Serological, Positive Control |
| Applicant | SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY Santee, CA 92071 |
| Contact | Richard Lenart |
| Correspondent | Richard Lenart SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY Santee, CA 92071 |
| Product Code | MJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-13 |
| Decision Date | 1997-12-24 |