The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Diagnostics Auto D-dimer, Model Crs126-a.
| Device ID | K003267 |
| 510k Number | K003267 |
| Device Name: | SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | William R Gilbert Ii |
| Correspondent | William R Gilbert Ii SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-18 |
| Decision Date | 2001-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391521420572 | K003267 | 000 |