This page includes the latest FDA filings for Clinical Genomics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3005311019 |
| FEI Number | 3005311019 |
| Name | Aileen Gilbert |
| Owner & Operator | CLINICAL GENOMICS |
| Contact Address | 236 Fernwood Avenue Edison NJ 08837 US |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1031 US Highway 202/206 Suite 100 Bridgewater, NJ 08807 US |
| Establishment Type |
|
| Registration Number | 1226769 |
| FEI Number | 3003224146 |
| Name | ENTERIX INC. |
| Owner & Operator | CLINICAL GENOMICS |
| Contact Address | 236 Fernwood Avenue Edison NJ 08837 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 236 Fernwood Ave EDISON, NJ 08837 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
ENTERIX INC. [CLINICAL GENOMICS] | InSure ONE | 2017-11-16 |
Aileen Gilbert [CLINICAL GENOMICS] | InSure ONE | 2017-11-16 |
ENTERIX INC. [CLINICAL GENOMICS] | InSure FIT FOBT Controls | 2014-09-05 |
ENTERIX INC. [CLINICAL GENOMICS] | MULTIPLE OCCULT BLOOD TEST | 2006-05-19 |
Aileen Gilbert [CLINICAL GENOMICS] | MULTIPLE OCCULT BLOOD TEST | 2006-05-19 |