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510(k) K963733

Device
NICCHECK I
Applicant
DYNAGEN, INC.
510(k) number
K963733
Product code
MRS  
Decision
Substantially Equivalent (SESE)
Decision date
1996-12-13
Date received
1996-09-16
Regulation
862.3220
Classification name
Test System, Nicotine, Cotinine, Metabolites
Medical specialty
Toxicology
Review panel
Toxicology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PETER J MIONE
Address
99 Erie St., Cambridge MA US 02139 02139

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MRS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K030649DRI COTININE EIA ASSAYMicrogenics Corp.2003-05-22
K021688NICALERTNymox Pharmaceutical Corporation2002-10-18

Legacy Summary#

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FDA Review#

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