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510(k) K936073

ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS by Chemicon Intl., Inc. — Product Code GNM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1995
Date Received
December 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
Device Class
Class I
Regulation Number
866.3145
Review Panel
MI
Submission Type

Other clearances by Chemicon Intl., Inc.

  • K992252 — LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 (August 10, 1999)
  • K940473 — ENTEROVIRUS 71 MONOCLONAL ANTIBODY (September 12, 1995)
  • K940027 — ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES (September 12, 1995)
  • K940472 — COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY (September 8, 1995)
  • K936145 — COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY (September 8, 1995)
  • K936089 — COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY (September 8, 1995)
  • K940471 — COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES (September 8, 1995)

Other clearances for product code GNM

  • K936253 — COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY (September 8, 1995)
  • K936254 — COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY (September 8, 1995)
  • K936089 — COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY (September 8, 1995)
  • K936145 — COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY (September 8, 1995)
  • K936252 — COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY (September 8, 1995)
  • K940471 — COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES (September 8, 1995)
  • K936251 — COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY (September 8, 1995)
  • K940472 — COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY (September 8, 1995)