510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861773Substantially Equivalent

Zygotek Microcomputerized Semen Analysis System

Zygotek Systems, Inc., Springfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861773 is the FDA 510(k) clearance record for ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM, a class I device, cleared for Zygotek Systems, Inc. on under FDA product code DGB (Seminal Fluid, Antigen, Antiserum, Control). FDA records list one 510(k) clearance for Zygotek Systems, Inc. As of , FDA records show no recalls naming K861773.

Clearance record

Decision date
Received
(61 days to decision)
Product code
DGB Seminal Fluid, Antigen, Antiserum, Control
Regulation
21 CFR 866.5800
Device class
Class I
Review panel
Immunology
Applicant
Zygotek Systems, Inc. 130 Maple St., Suite 232, Springfield MA
Third party review
No

Clearances, product code DGB

Trailing 12 months

FDA records hold no clearances under product code DGB in the trailing twelve months.

FDA records show no clearances under product code DGB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DGB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260