FDA Registration
Active
🇺🇸 United States
Pinto Beans (F300L2); Red Kidney Bean (F287L2)
Reg #: 2432235
·
FEI: 2432235
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Siemens Healthcare Diagnostics Inc.
- Registration Number
- 2432235
- FEI Number
- 2432235
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 511 Benedict Ave
- City
- Tarrytown
- State
- NY
- ZIP
- 10591
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093107
Owner / Operator
- Firm Name
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Operator Number
- 9096044
- Address
- Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
- City
- Tarrytown
- State
- NY
- Postal Code
- 10591
- Country
- US
- Correspondent
- Mary Seeger
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Radioallergosorbent (Rast) Immunological | DHB | Class 2 | Immunology | No | 2010-12-09 |
Proprietary Names
Pinto Beans (F300L2); Red Kidney Bean (F287L2)
Halibut (F303L2); Mushroom (F212L2)
Cinnamon (F220L2); Flounder (F147L2);
Brewer's Yeast (F403L2); Cantaloupe (F102L2);
IMMULITE 2000 3gAllergy Specific IgE
Green Bean (F315L2); Green Pepper (F263L2)
Sugar Cane (F21L2); Yogurt (F360L2)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility