The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Factor Ix Deficient Plasma.
| Device ID | K900409 |
| 510k Number | K900409 |
| Device Name: | FACTOR IX DEFICIENT PLASMA |
| Classification | Plasma, Coagulation Factor Deficient |
| Applicant | SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | Lawson, Phd |
| Correspondent | Lawson, Phd SIGMA CHEMICAL CO. 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 | 1990-01-29 |
| Decision Date | 1990-03-06 |