COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY— 510(k) K936252

Name: FDA 510(k) clearance K936252
Creator: U.S. Food and Drug Administration
Published: 1995-09-08

Substantially Equivalent

Light Diagnostics

FDA 510(k) clearance K936252 for COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY, Substantially Equivalent on 1995-09-08. Applicant: Light Diagnostics. Device class: 1.

Clearance details

Applicant: Light Diagnostics
Product code: Code GNM
Device class: Class 1
Regulation: 21 CFR 866.3145
Advisory panel: Microbiology
Date received: 1993-12-30
Decision date: 1995-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GNM

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K936073 — ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS1995-09-08
K936089 — COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY1995-09-08
K936145 — COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY1995-09-08
K936251 — COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY1995-09-08
K936253 — COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY1995-09-08

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