Home / 510(k) Clearances / K853468

510(k) K853468

GILFORD C4 COMPLEMENT REAGENT by Gilford — Product Code DBI

K853468 is an FDA 510(k) premarket notification submitted by Gilford for the device "GILFORD C4 COMPLEMENT REAGENT". The FDA issued a decision of Substantially Equivalent on September 16, 1985. The device falls under product code DBI (Complement C4, 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
September 16, 1985
Date Received
August 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C4, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
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)
  • K853469 — GILFORD IMMUNOGLOBULIN M 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 DBI

  • K100455 — SPAPLUS ANALYZER (September 3, 2010)
  • K012359 — TINA-QUANT COMPLEMENT C4 TEST SYSTEM (November 29, 2001)
  • K010325 — WAKO AUTOKIT C4 (June 25, 2001)
  • K000468 — RANDOX COMPLEMENT C4 (March 27, 2000)
  • K994293 — DIMENSION C4 FLEX REAGENT CARTRIDGE (March 1, 2000)
  • K981785 — C4 MININEPH ANTISERUM (December 20, 1999)
  • K993481 — K-ASSAY C4 (November 29, 1999)
  • K983356 — C4 (November 4, 1998)
  • K964300 — N-ASSAY TIA MULTI V-NL (July 14, 1997)
  • K964297 — N-ASSAY TIA C4 TEST KIT (July 14, 1997)

FDA data resources