Cleared Traditional

EB-VCA, TEST, ANTIBODY, FLUORESCENT

K780925 · Litton Bionetics · Microbiology

Jun 1978

Decision

16d

Days

Class 1

Risk

About This 510(k) Submission

K780925 is an FDA 510(k) clearance for the EB-VCA, TEST, ANTIBODY, FLUORESCENT, a Antiserum, Fluorescent, Epstein-barr Virus (Class I — General Controls, product code JRY), submitted by Litton Bionetics (Mchenry, US). The FDA issued a Cleared decision on June 22, 1978, 16 days after receiving the submission on June 6, 1978. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number	K780925 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 1978
Decision Date	June 22, 1978
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—