FDA Registration
Active
🇺🇸 United States
BioClinica, Inc.
Reg #: 1126271
·
FEI: 1000263641
·
Expires 2026
Products
9
Proprietary Names
15
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- BioClinica, Inc.
- Registration Number
- 1126271
- FEI Number
- 1000263641
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1818 Market Street
- City
- Philadelphia
- State
- PA
- ZIP
- 19103
- Country
- US
Regulatory Submissions
- 510(k) Number
- K051730
Owner / Operator
- Firm Name
- Bioclinica, Inc.
- Operator Number
- 10023650
- Address
- 1501 Grundy Lane, Suite A
- City
- Bristol
- State
- PA
- Postal Code
- 19007
- Country
- US
- Correspondent
- Christopher R Levinton
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | Class 2 | Cardiovascular | No | 2010-10-01 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-03-07 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2022-06-01 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2022-06-01 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2022-06-01 |
| System, Gastrointestinal Motility (Electrical) | FFX | Class 2 | Gastroenterology, Urology | No | 2025-03-13 |
| LOS | No | 2009-12-15 | |||
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2009-12-15 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2012-06-13 |
Proprietary Names
GI M12R
Tel-O-Graph
Clarius L20 HD3
Endoflip nasal tip catheter
MAC 1200
IEM HMS-CS
H12+
Welch Allyn ELI150C
Watch BP HOME A
Welch Allyn ELI280
Welch Allyn ELI250C
WATCHBP O3
90217A
Watch BP Office AFIB
WatchBP Office 2G
Establishment Types
Repack or Relabel Medical Device