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510(k) K012576

CIC-C1Q EIA by American Laboratory Products Co., Ltd. — Product Code DAK

K012576 is an FDA 510(k) premarket notification submitted by American Laboratory Products Co., Ltd. for the device "CIC-C1Q EIA". The FDA issued a decision of Substantially Equivalent on January 29, 2002. The device falls under product code DAK (Complement C1q, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. American Laboratory Products Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2002
Date Received
August 9, 2001
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 American Laboratory Products Co., Ltd.

  • K011415 — ALPCO MILENIA ANTI-TG EIA (May 30, 2001)
  • K011201 — ALPCO MILENIA ANTI-TPO ELISA (May 24, 2001)
  • K974702 — ORGENTEC ANTI-PR3 (C-ANCA) ELISA (February 17, 1998)
  • K974701 — ORGENTEC ANTI-MPO (P-ANCA) ELISA (February 17, 1998)
  • K972190 — THYROGLOBULIN ASSAY SYSTEM (July 14, 1997)
  • K970932 — ORGENTEC MICRO-ALBUMIN EIA ASSAY (April 8, 1997)
  • K962062 — ORGENTEC ANTI-SM ELISA (November 18, 1996)
  • K962057 — ORGENTEC ANTI-RNP/SM ELISA (November 18, 1996)
  • K962053 — ORGENTEC ANTI-JO-1 ELISA (November 15, 1996)
  • K962054 — ORGENTEC ANTI-SS-A(RO) ELISA (November 15, 1996)

Other clearances for product code DAK

  • K031563 — BINDAZYME CLQ CIC EIA KIT (September 10, 2003)
  • K032254 — IBL C1Q-CIC CIA TEST (August 29, 2003)
  • 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