The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Activated Partial Thromboplastin Time (aptt).
| Device ID | K896545 |
| 510k Number | K896545 |
| Device Name: | ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) |
| Classification | Activated Partial Thromboplastin |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Daniel E Lawson,phd |
| Correspondent | Daniel E Lawson,phd SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-17 |
| Decision Date | 1989-12-01 |