The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Prekallikrein Deficient Plasma, Cat. No. B 6765.
| Device ID | K861048 |
| 510k Number | K861048 |
| Device Name: | PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765 |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | SIGMA CHEMICAL CO. POST OFFICE BOX 14508 St. Louis, MO 63278 |
| Contact | Leo Bressler |
| Correspondent | Leo Bressler SIGMA CHEMICAL CO. POST OFFICE BOX 14508 St. Louis, MO 63278 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-19 |
| Decision Date | 1986-05-29 |