Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM

K-Number: K861773 · 1986-07-07

ApplicantZygotek Systems, Inc.
Decision Date1986-07-07
Product CodeDGB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zygotek Systems, Inc.. It received FDA 510(k) clearance on 1986-07-07 under 510(k) number K861773. The device is classified under product code DGB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM?

ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1986-07-07. The listed applicant is Zygotek Systems, Inc.. The 510(k) number is K861773.

When did ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM receive FDA 510(k) clearance?

ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM received FDA 510(k) clearance on 1986-07-07, under 510(k) number K861773.

Who is the listed applicant for ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM?

The FDA 510(k) record lists Zygotek Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM?

The FDA product code for ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM is DGB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑