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510(k) K940473

ENTEROVIRUS 71 MONOCLONAL ANTIBODY by Chemicon Intl., Inc. — Product Code GOE

K940473 is an FDA 510(k) premarket notification submitted by Chemicon Intl., Inc. for the device "ENTEROVIRUS 71 MONOCLONAL ANTIBODY". The FDA issued a decision of Substantially Equivalent on September 12, 1995. The device falls under product code GOE (Antisera, Fluorescent, Poliovirus 1-3), a Class I device regulated under 21 CFR 866.3405. Chemicon Intl., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1995
Date Received
February 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Poliovirus 1-3
Device Class
Class I
Regulation Number
866.3405
Review Panel
MI
Submission Type

Other clearances by Chemicon Intl., Inc.

  • K992252 — LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 (August 10, 1999)
  • K940027 — ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES (September 12, 1995)
  • K936145 — COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY (September 8, 1995)
  • K940471 — COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES (September 8, 1995)
  • K936073 — ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS (September 8, 1995)
  • K936089 — COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY (September 8, 1995)
  • K940472 — COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY (September 8, 1995)

Other clearances for product code GOE

  • K940026 — POLIOVIRUS BLEND MONOCLONAL ANTIBODIES (September 12, 1995)
  • K940027 — ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES (September 12, 1995)
  • K940017 — POLIOVIRUS 3 MONOCLONAL ANTIBODY (September 12, 1995)
  • K940034 — POLIOVIRUS 2 MONOCLONAL ANTIBODY (September 12, 1995)
  • K940018 — POLIOVIRUS 1 MONOCLONAL ANTIBODY (September 8, 1995)
  • K940363 — ENTEROVIRUS 70 MONCLONAL ANTIBODY (September 8, 1995)

FDA data resources