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510(k) K833067

IMPACT 400 #1447X2 by Gilford — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1983
Date Received
September 8, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

Other clearances by Gilford

  • K853468 — GILFORD C4 COMPLEMENT REAGENT (September 16, 1985)
  • K853466 — GILFORD C3 COMPLEMENT REAGENT (September 16, 1985)
  • K853469 — GILFORD IMMUNOGLOBULIN M REAGENT (September 16, 1985)
  • 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)
  • K812787 — EIA RUBELLA (November 27, 1981)

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