FDA.reportPublic FDA data

EmCyte Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10664913003429569EmCyte Corporation1N2026-01-014331 Veronica S. Shoemaker Blvd. FORT MYERS FL US 33916

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00855306003466AbsoluteBMC 30mL GenesisCS Component Concentrating System - GSBMA-30+1(239)482-7725support@emcyte.com
00855306003503AcCELLerated Biologics PURE PRP II 60mL GenesisCS Component Concentrating System - AB60-PURE+1(239)482-7725support@emcyte.com
00855306003510PureSpin PRP Platelet Concentrating System 30mL - PS30-PURE+1(239)482-7725support@emcyte.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
594861707940160K191564Progenikine Concentrating System 25 mL SystemMUU2019-11-07
594861240575123K183205PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL SystemJQC2019-05-30
594861128655962K070666GENESISCS COMPONENT CONCENTRATING SYSTEMJQC2007-06-20
594861260086834K024080SECQUIRE CELL SEPARATORJQC2003-07-02
594861236550830BK190317
594861406819230BK130079
594861565908773BK050055
594861304562672
594861920783154
594861460720032
594861592473678
594861698522984
594862058963556

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JQC62019-05-30
MUU22019-11-07

PMN#

GUDID#