FDA 510(k) K912061, HEPARIN ADSORBENT, by Sigma Diagnostics, Inc.
FDA 510(k) K912061, HEPARIN ADSORBENT, by Sigma Diagnostics, Inc.
| 510(k) Number | K912061 |
| Device Classification Name | System, Multipurpose For In Vitro Coagulation Studies |
| Device Name | HEPARIN ADSORBENT |
| Applicant | Sigma Diagnostics, Inc. 545 S. Ewing Ave. St. Louis, MO 63103 |
| Regulation Number | 864.5425 |
| Classification Product Code | JPA |
| Date Received | 05/09/1991 |
| Decision Date | 07/24/1991 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Hematology |
| 510k Review Panel | Hematology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 50 |
| Redacted Pages | 4 |
| Unredacted Pages | 46 |
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