Device Classification Name |
seminal fluid, antigen, antiserum, control
|
510(k) Number |
K861773 |
Device Name |
ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM |
Applicant |
ZYGOTEK SYSTEMS, INC. |
130 MAPLE ST., SUITE 232 |
SPRINGFIELD,
MA
01103
|
|
Applicant Contact |
RICHARD B DARDAS |
Correspondent |
ZYGOTEK SYSTEMS, INC. |
130 MAPLE ST., SUITE 232 |
SPRINGFIELD,
MA
01103
|
|
Correspondent Contact |
RICHARD B DARDAS |
Regulation Number | 866.5800
|
Classification Product Code |
|
Date Received | 05/07/1986 |
Decision Date | 07/07/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|