Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1066491

FEI Number

3003429569

Entity Name

EmCyte Corporation

City/State/Country

FORT MYERS, FL, US

Establishment Address

4331 Veronica S. Shoemaker Blvd., FORT MYERS, FL 33916, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

EmCyte Corporation (Owner Number: 9047034)

Owner / Operator Contact Address

4331 Veronica S. Shoemaker Blvd., --, Fort Myers, FL 33916, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic Use	Hematology	Class 1	864.9275	2001-07-25
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2019-07-01
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-07-01
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2011-09-14
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2011-09-14
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2007-11-06
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2011-09-14
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2019-05-07
MUU	System, Suction, Lipoplasty	General, Plastic Surgery	Class 2	878.5040	2019-11-19
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2024-04-10

Official Correspondent

PATRICK PENNIE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EmCyte Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K812750	Instrumentation Laboratory CO	IL 703, STAT SEPARATOR	1982-01-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

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3042991841	ITAS G PHARMA	Guwahati Assam, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1066491. Last updated year: 2026. Please use registration number 1066491 when referencing this establishment in official correspondence.