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510(k) K770811

ADENOVIRUS GROUP-FA LABELLED PRESERUM by Flow Laboratories, Inc. — Product Code GNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1977
Date Received
May 3, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Adenovirus 1-33
Device Class
Class I
Regulation Number
866.3020
Review Panel
MI
Submission Type

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  • K850908 — TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA (March 25, 1985)
  • K844419 — TITERTEK MULTISKAN MSS/340 (March 21, 1985)
  • K844418 — TITERTEK MULTISKAN MCC (March 21, 1985)

Other clearances for product code GNY

  • K922801 — RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY (January 6, 1993)
  • K885310 — MURINE MONOCLONAL ANTI-ADENOVIRUS IGG (February 16, 1989)
  • K770807 — ADENOVIRUS-GROUP FA LABELLED (8-651 RF) (May 20, 1977)