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510(k) K853469

GILFORD IMMUNOGLOBULIN M REAGENT by Gilford — Product Code DFT

K853469 is an FDA 510(k) premarket notification submitted by Gilford for the device "GILFORD IMMUNOGLOBULIN M REAGENT". The FDA issued a decision of Substantially Equivalent on September 16, 1985. The device falls under product code DFT (Igm, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. 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
Igm, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

Other clearances by Gilford

  • K853467 — GILFORD IMMUNOGLOBULIN A REAGENT (September 16, 1985)
  • K853465 — GILFORD IMMUNOGLOBULIN G REAGENT (September 16, 1985)
  • K853466 — GILFORD C3 COMPLEMENT REAGENT (September 16, 1985)
  • K853468 — GILFORD C4 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 DFT

  • K983132 — IGM (November 4, 1998)
  • K962201 — QUANTEX IGM (September 25, 1996)
  • K955797 — IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR (April 5, 1996)
  • K945522 — I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS (December 12, 1994)
  • K901453 — QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD (April 12, 1990)
  • K894417 — RAICHEM(TM) SPIA(TM) IGM REAGENTS (August 2, 1989)
  • K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (October 27, 1988)
  • K880828 — WAKO(TM) IGM-HA DIRECT (March 25, 1988)
  • K873871 — IMMUNOGLOBULINS M (October 13, 1987)
  • K872237 — KALLESTAD QM300 IGM ANTIBODY PACK (July 9, 1987)

FDA data resources