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510(k) K851202

GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL by Gilford — Product Code DAK

K851202 is an FDA 510(k) premarket notification submitted by Gilford for the device "GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL". The FDA issued a decision of Substantially Equivalent on April 29, 1985. The device falls under product code DAK (Complement C1q, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Gilford has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1985
Date Received
March 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C1q, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
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)
  • K853465 — GILFORD IMMUNOGLOBULIN G REAGENT (September 16, 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 DAK

  • K031563 — BINDAZYME CLQ CIC EIA KIT (September 10, 2003)
  • K032254 — IBL C1Q-CIC CIA TEST (August 29, 2003)
  • K012576 — CIC-C1Q EIA (January 29, 2002)
  • K973203 — THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODI (September 30, 1998)
  • K972873 — IMMUSTRIP HAMA IGG (March 17, 1998)
  • K951968 — HUMAN C1Q RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K914388 — C1 RID KIT (October 28, 1991)
  • K882829 — CIRCULATING IMMUNE COMPLEXES CONTROLS (August 4, 1988)
  • K860996 — SANASSAY IC TEST (March 30, 1987)
  • K864312 — IC MICROASSAY (January 9, 1987)

FDA data resources