Cleared Traditional

CYTOTECH HSV IGG ENZYME IMMUNOASSAY

K862838 · Cytotech, Inc. · Microbiology

Dec 1986

Decision

137d

Days

Class 2

Risk

About This 510(k) Submission

K862838 is an FDA 510(k) clearance for the CYTOTECH HSV IGG ENZYME IMMUNOASSAY, a Endoscope, Mirror (Class II — Special Controls, product code GCO), submitted by Cytotech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 9, 1986, 137 days after receiving the submission on July 25, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K862838 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 1986
Decision Date	December 09, 1986
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—