FDA.reportPublic FDA data

OptiScan Biomedical Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30109007253010900725OptiScan Biomedical Corporation1N2020-04-2524590 Clawiter Rd Hayward CA US 94545

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
00850003892054OptiScanner 5000 Disposable Cartridge - OptiScanner Disposable Cartridge510.342.5818edeperalta@optiscancorp.com
00850003892054OptiScanner 5000 Disposable Cartridge - OptiScanner Disposable Cartridge510.962.6207ccastillo@optiscancorp.com
00850003892504OptiScanner 5000 Glucose Monitoring System - Automated, in-line, bedside, glucose monitoring system510.962.6207ccastillo@optiscancorp.com
00850003892504OptiScanner 5000 Glucose Monitoring System - Automated, in-line, bedside, glucose monitoring system510.342.5818edeperalta@optiscancorp.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1713401774523779K162042OptiScanner 5000 Glucose Monitoring SystemLZF2017-10-16
1713401999487856

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZF12017-10-16

PMN#

GUDID#