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510(k) K012576

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

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

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Other clearances for product code DAK

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  • 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)