The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Aptt Reagent.
| Device ID | K904341 |
| 510k Number | K904341 |
| Device Name: | APTT REAGENT |
| Classification | Activated Partial Thromboplastin |
| Applicant | SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | Daniel E Lawson,phd |
| Correspondent | Daniel E Lawson,phd SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-20 |
| Decision Date | 1990-11-08 |