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510(k) K936251

COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY by Light Diagnostics — Product Code GNM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1995
Date Received
December 30, 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

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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)
  • K936073 — ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS (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)
  • K940472 — COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY (September 8, 1995)