The following data is part of a premarket notification filed by Pathway Llc with the FDA for Kurin Blood Culture Collection Set.
| Device ID | K162233 |
| 510k Number | K162233 |
| Device Name: | Kurin Blood Culture Collection Set |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Pathway LLC 8779 Cottonwood Ave., Suite 105 Santee, CA 92071 |
| Contact | Emily Davis |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-08-08 |
| Decision Date | 2016-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857606008202 | K162233 | 000 |
| 20857606008411 | K162233 | 000 |
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| 20857606008107 | K162233 | 000 |