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510(k) K853465

GILFORD IMMUNOGLOBULIN G REAGENT by Gilford — Product Code DEW

K853465 is an FDA 510(k) premarket notification submitted by Gilford for the device "GILFORD IMMUNOGLOBULIN G REAGENT". The FDA issued a decision of Substantially Equivalent on September 16, 1985. The device falls under product code DEW (Igg, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Gilford has at least 9 other 510(k) clearances on record.

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
Igg, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Gilford

  • K853469 — GILFORD IMMUNOGLOBULIN M REAGENT (September 16, 1985)
  • K853468 — GILFORD C4 COMPLEMENT REAGENT (September 16, 1985)
  • K853467 — GILFORD IMMUNOGLOBULIN A REAGENT (September 16, 1985)
  • K853466 — GILFORD C3 COMPLEMENT 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)

Other clearances for product code DEW

  • K050113 — TINA-QUANT IGG GEN.2 (February 8, 2005)
  • K040434 — ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (March 10, 2004)
  • K010617 — SPIFE IFE CALIBRATOR AND CONTROL KIT (March 15, 2001)
  • K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (January 18, 2000)
  • K993281 — K-ASSAY IGG (November 9, 1999)
  • K983221 — IGG (November 4, 1998)
  • K965108 — SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (March 6, 1997)
  • K963974 — IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (March 6, 1997)
  • K963868 — IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (February 10, 1997)
  • K962202 — QUANTEX IGG (September 26, 1996)

FDA data resources