The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Factor Viii Deficient Plasma.
| Device ID | K935057 |
| 510k Number | K935057 |
| Device Name: | FACTOR VIII DEFICIENT PLASMA |
| Classification | Plasma, Coagulation Factor Deficient |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | Daniel E Lawson |
| Correspondent | Daniel E Lawson SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | GJT |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-21 |
| Decision Date | 1994-03-15 |