The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Anti Ds-dna.
| Device ID | K943291 |
| 510k Number | K943291 |
| Device Name: | ANTI DS-DNA |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | Timothy J Perko |
| Correspondent | Timothy J Perko SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-08 |
| Decision Date | 1994-12-02 |