The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Heparin Adsorbent.
| Device ID | K912061 |
| 510k Number | K912061 |
| Device Name: | HEPARIN ADSORBENT |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | Daniel Lawson,p.hd. |
| Correspondent | Daniel Lawson,p.hd. SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-09 |
| Decision Date | 1991-07-24 |