The following data is part of a premarket notification filed by Radiometer America Inc. with the FDA for Vk-3 Verification Kit, Vk-4 Verification Kit, Vk-r5 Verification Kit, Vk-r7 Verification Kit, Vk-crea Verification Kit.
| Device ID | K153712 |
| 510k Number | K153712 |
| Device Name: | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | RADIOMETER AMERICA INC. 250 S. KRAEMER BLVD Brea, CA 92821 |
| Contact | Matt Ackerman |
| Correspondent | Karen Bang Jakobsen RADIOMETER MEDICAL APS AAKANDEVEJ 21 Broenshoej, DK 2700 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-24 |
| Decision Date | 2016-01-28 |
| Summary: | summary |