ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM— 510(k) K861773

Name: FDA 510(k) clearance K861773
Creator: U.S. Food and Drug Administration
Published: 1986-07-07

Substantially Equivalent

Zygotek Systems, Inc.

FDA 510(k) clearance K861773 for ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM, Substantially Equivalent on 1986-07-07. Applicant: Zygotek Systems, Inc.. Device class: 1.

Clearance details

Applicant: Zygotek Systems, Inc.
Product code: Code DGB
Device class: Class 1
Regulation: 21 CFR 866.5800
Advisory panel: Immunology
Date received: 1986-05-07
Decision date: 1986-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, MA, US

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