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510(k) K050596

QUANTIA A1-AT by Biokit, S.A. — Product Code DEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2005
Date Received
March 8, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5130
Review Panel
IM
Submission Type

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Other clearances for product code DEM

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  • K053072 — N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN (March 28, 2006)
  • K052819 — VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VER (December 23, 2005)
  • K031857 — ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY (September 4, 2003)
  • K011663 — MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS (July 30, 2001)
  • K010978 — TINA-QUANT ALPHA-1 ANTITRYPSIN (May 18, 2001)
  • K993444 — K-ASSAY ALPHA-1 AT (November 24, 1999)
  • K972640 — TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY (January 9, 1998)
  • K973389 — CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING (October 3, 1997)