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510(k) K032254

IBL C1Q-CIC CIA TEST by Ibl GmbH — Product Code DAK

K032254 is an FDA 510(k) premarket notification submitted by Ibl GmbH for the device "IBL C1Q-CIC CIA TEST". The FDA issued a decision of Substantially Equivalent on August 29, 2003. The device falls under product code DAK (Complement C1q, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Ibl GmbH has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2003
Date Received
July 22, 2003
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 Ibl GmbH

  • K051969 — TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENAL (October 3, 2005)
  • K041349 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM (September 24, 2004)
  • K040923 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA (July 22, 2004)
  • K033786 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIV (February 27, 2004)
  • K032796 — IBL C3D-CIC EIA TEST (January 13, 2004)

Other clearances for product code DAK

  • K031563 — BINDAZYME CLQ CIC EIA KIT (September 10, 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)
  • K862649 — CYTOTECH CIC ENZYME IMMUNOASSAY (September 4, 1986)

FDA data resources