510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862838Substantially Equivalent

Cytotech Hsv Igg Enzyme Immunoassay

Cytotech, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862838 is the FDA 510(k) clearance record for CYTOTECH HSV IGG ENZYME IMMUNOASSAY, a class II device, cleared for Cytotech, Inc. on under FDA product code GCO (Endoscope, Mirror). FDA records list 10 510(k) clearances for Cytotech, Inc., from to . As of , FDA records show no recalls naming K862838.

Clearance record

Decision date
Received
(137 days to decision)
Product code
GCO Endoscope, Mirror
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cytotech, Inc. 11035 Roselle St., Suite A, San Diego CA
Third party review
No

Clearances, product code GCO

Trailing 12 months

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

FDA records show no clearances under product code GCO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GCO, 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