The following data is part of a premarket notification filed by Astute Medical, Inc with the FDA for Nephrocheck Test Kit, Astute140 Meter, Nephrocheck Liquid Controls Kit, Nephrocheck Calibration Verification (cal Vers) Kit.
| Device ID | K153165 |
| 510k Number | K153165 |
| Device Name: | NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit |
| Classification | Acute Kidney Injury Test System |
| Applicant | ASTUTE MEDICAL, INC 3550 GENERAL ATOMICS COURT BUILDING 2, R 432 San Diego, CA 92121 |
| Contact | Karin Hughes |
| Correspondent | Janice Hogan HOGAN LOVELLS US LLP 1835 MARKET STREET 29TH FL Philadelphia, PA 19103 |
| Product Code | PIG |
| CFR Regulation Number | 862.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-02 |
| Decision Date | 2016-06-01 |
| Summary: | summary |