This page includes the latest FDA filings for Astute Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Astute Medical Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3009834061 |
| FEI Number | 3009834061 |
| Name | Astute Medical, Inc. |
| Owner & Operator | Astute Medical, Inc |
| Contact Address | 3550 General Atomics Ct Building 2 San Diego CA 92121 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 3550 General Atomics Ct San Diego, CA 92121 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
Astute Medical, Inc. [Astute Medical, Inc] | NephroCheck Test Kit | 2019-03-07 |
Astute Medical, Inc. [Astute Medical, Inc] | NephroCheck Liquid Controls Kit | 2019-03-07 |
Astute Medical, Inc. [Astute Medical, Inc] | NephroCheck Calibration Verification (Cal Vers) Kit | 2019-03-07 |
Astute Medical, Inc. [Astute Medical, Inc] | Astute140 Meter Kit | 2019-03-07 |
Astute Medical, Inc. [Astute Medical, Inc] | Astute140 Meter Electronic Quality Control (EQC) Device | 2019-03-07 |
| ASTUTE MEDICAL, INC. | ASTUTE140 Meter Kit 500017 | 2018-03-29 |
| ASTUTE MEDICAL, INC. | NEPHROCHECK Liquid Control Kit 500013 | 2018-03-29 |
| ASTUTE MEDICAL, INC. | NEPHROCHECK Test Kit 500011 | 2018-03-29 |
| ASTUTE MEDICAL, INC. | NEPHROCHECK Calibration Verification (Cal Vers) Ki 500009 | 2018-03-29 |
| ASTUTE MEDICAL, INC. | ASTUTE140 Electronic Quality Control (EQC) Device 400016 | 2018-03-29 |
Astute Medical, Inc. | NEPHROCHECK Test System | 2017-11-16 |
ASTUTE MEDICAL, INC | NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit | 2016-06-01 |
| NCAGE Code | 5CPJ6 | ASTUTE MEDICAL, INC.!DBA ASTUTE |
| CAGE Code | 5CPJ6 | ASTUTE MEDICAL, INC. ASTUTE |
| S.A.M. Registration | 5CPJ6 [942854212] | ASTUTE MEDICAL, INC. ASTUTE |
| DUNS | 942854212 | Astute Medical, Inc. |
| SEC | 0001432372 | Astute Medical, Inc. of DELAWARE |