FDA.reportPublic FDA data

510(k) K861773

Device
ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM
Applicant
ZYGOTEK SYSTEMS, INC.
510(k) number
K861773
Product code
DGB  
Decision
Substantially Equivalent (SESE)
Decision date
1986-07-07
Date received
1986-05-07
Regulation
866.5800
Classification name
Seminal Fluid, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RICHARD B DARDAS
Address
130 Maple St., Suite 232 Springfield MA US 01103 01103

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases