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510(k) K853469

GILFORD IMMUNOGLOBULIN M REAGENT by Gilford — Product Code DFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1985
Date Received
August 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igm, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

Other clearances by Gilford

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  • K853465 — GILFORD IMMUNOGLOBULIN G REAGENT (September 16, 1985)
  • K853467 — GILFORD IMMUNOGLOBULIN A REAGENT (September 16, 1985)
  • K851202 — GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL (April 29, 1985)
  • K842500 — DATA MGMT. SYSTEM (August 16, 1984)
  • K840120 — ADVANTAGE (March 23, 1984)
  • K833067 — IMPACT 400 #1447X2 (December 8, 1983)
  • K812787 — EIA RUBELLA (November 27, 1981)

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