FDA Registration
Active
🇺🇸 United States
EmCyte Corporation
Reg #: 1066491
·
FEI: 3003429569
·
Expires 2026
Products
9
Proprietary Names
23
Establishment Types
2
Classifications
9
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Registration Details
- Registration Name
- EmCyte Corporation
- Registration Number
- 1066491
- FEI Number
- 3003429569
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4331 Veronica S. Shoemaker Blvd.
- City
- FORT MYERS
- State
- FL
- ZIP
- 33916
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183205
Owner / Operator
- Firm Name
- EmCyte Corporation
- Operator Number
- 9047034
- Address
- 4331 Veronica S. Shoemaker Blvd., --
- City
- Fort Myers
- State
- FL
- Postal Code
- 33916
- Country
- US
- Correspondent
- PATRICK - PENNIE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Centrifuge, Blood-Bank For In Vitro Diagnostic Use | KSO | Class 1 | Hematology | No | 2001-07-25 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2019-07-01 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2019-07-01 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2007-11-06 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2019-05-07 |
| System, Suction, Lipoplasty | MUU | Class 2 | General, Plastic Surgery | No | 2019-11-19 |
| Unit, Filter, Membrane | JRL | Class 1 | Clinical Chemistry | No | 2024-04-10 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2020-01-28 |
| Adaptor, Holder, Syringe | IQG | Class 1 | Physical Medicine | No | 2012-07-13 |
Proprietary Names
EXECUTIVE SERIES CENTRIFUGE
PUREBMC SUPRAPHYSIOLOGIC CONCENTRATING SYSTEM 60mL
PUREBMC SUPRAPHYSIOLOGIC CONCENTRATING SYSTEM 120mL
PUREBMC SUPRAPHYSIOLOGIC CONCENTRATING SYSTEM 30mL
ABSOLUTEPRP CONCENTRATING SYSTEM
GENESISCS COMPONENT CONCENTRATING SYSTEM PLATELET CONCENTRATE
PUREPRP TWO SEPARATOR SYSTEM
PURESPIN PRP
GENESISCS COMPONENT CONCENTRATING SYSTEM BONE MARROW
ABSOLUTEBMC CONCENTRATING SYSTEM
PUREBMC TWO SEPARATOR SYSTEM
QuickDraw Delivery System
SECQUIRE CELL SEPARATOR WITH ANTICOAGULANT SODIUM CITRATE SOLUTION USP
PURE TWO CONCENTRATOR
ASPIRE Bone Marrow Harvesting System
PROGENIKINE CONCENTRATING SYSTEM
CORE Ultrafiltration System
PUREPRP SUPRAPHYSIOLOGIC CONCENTRATING SYSTEM 120mL
PUREPRP SUPRAPHYSIOLOGIC CONCENTRATING SYSTEM 30mL
PUREPRP SUPRAPHYSIOLOGIC CONCENTRATING SYSTEM 60mL
Centrepid Platelet Concentrator
SAPPHIRE SERIES CENTRIFUGE
BONE GRAFT SYRINGE HOLDER
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device