The following data is part of a premarket notification filed by Zygotek Systems, Inc. with the FDA for Zygotek Microcomputerized Semen Analysis System.
| Device ID | K861773 |
| 510k Number | K861773 |
| Device Name: | ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM |
| Classification | Seminal Fluid, Antigen, Antiserum, Control |
| Applicant | ZYGOTEK SYSTEMS, INC. 130 MAPLE ST., SUITE 232 Springfield, MA 01103 |
| Contact | Richard B Dardas |
| Correspondent | Richard B Dardas ZYGOTEK SYSTEMS, INC. 130 MAPLE ST., SUITE 232 Springfield, MA 01103 |
| Product Code | DGB |
| CFR Regulation Number | 866.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-07 |
| Decision Date | 1986-07-07 |