The following data is part of a premarket notification filed by Quantimetrix Corporation with the FDA for Dropper Hscrp High Sensitivity Crp Control.
| Device ID | K152117 |
| 510k Number | K152117 |
| Device Name: | Dropper HsCRP High Sensitivity CRP Control |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Quantimetrix Corporation 2005 Manhattan Beach Blvd Redondo Beach, CA 90278 |
| Contact | Kaylna Snylyk |
| Correspondent | Kaylna Snylyk Quantimetrix Corporation 2005 Manhattan Beach Blvd Redondo Beach, CA 90278 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-30 |
| Decision Date | 2016-04-21 |
| Summary: | summary |