COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY— 510(k) K936089

Name: FDA 510(k) clearance K936089
Creator: U.S. Food and Drug Administration
Published: 1995-09-08

Substantially Equivalent

Chemicon Intl., Inc.

FDA 510(k) clearance K936089 for COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY, Substantially Equivalent on 1995-09-08. Applicant: Chemicon Intl., Inc.. Device class: 1.

Clearance details

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

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Recent devices under product code GNM

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K936073 — ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS1995-09-08
K936145 — COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY1995-09-08
K936251 — COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY1995-09-08
K936252 — COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY1995-09-08
K936253 — COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY1995-09-08

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K992252 — LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 319651999-08-10
K940027 — ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES1995-09-12
K940473 — ENTEROVIRUS 71 MONOCLONAL ANTIBODY1995-09-12
K940471 — COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES1995-09-08
K940472 — COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY1995-09-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.