The following data is part of a premarket notification filed by Kurin, Inc with the FDA for Kurin Blood Culture Collection Set With Kurin Lock Technology, Push-button Needle (product Models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223).
| Device ID | K191832 |
| 510k Number | K191832 |
| Device Name: | Kurin Blood Culture Collection Set With Kurin Lock Technology, Push-Button Needle (Product Models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Kurin, Inc 10840 Thornmint Road, Suite 111 San Diego, CA 92127 |
| Contact | Neal Hartman |
| Correspondent | Neal Hartman Kurin, Inc 10840 Thornmint Road, Suite 111 San Diego, CA 92127 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-09 |
| Decision Date | 2020-02-04 |