ENTEROVIRUS 70 MONCLONAL ANTIBODY— 510(k) K940363

Name: FDA 510(k) clearance K940363
Creator: U.S. Food and Drug Administration
Published: 1995-09-08

Substantially Equivalent

Light Diagnostics

FDA 510(k) clearance K940363 for ENTEROVIRUS 70 MONCLONAL ANTIBODY, Substantially Equivalent on 1995-09-08. Applicant: Light Diagnostics. Device class: 1.

Clearance details

Applicant: Light Diagnostics
Product code: Code GOE
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1994-01-26
Decision date: 1995-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

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