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510(k) K010978

TINA-QUANT ALPHA-1 ANTITRYPSIN by Rochdiag — Product Code DEM

K010978 is an FDA 510(k) premarket notification submitted by Rochdiag for the device "TINA-QUANT ALPHA-1 ANTITRYPSIN". The FDA issued a decision of Substantially Equivalent on May 18, 2001. The device falls under product code DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5130. Rochdiag has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2001
Date Received
March 13, 2001
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

Other clearances by Rochdiag

  • K063744 — COBAS INTEGRA C 111 (January 17, 2007)
  • K011658 — CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS (July 31, 2001)

Other clearances for product code DEM

  • K123256 — HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS (July 3, 2013)
  • K063610 — DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL (January 11, 2007)
  • 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)
  • K050596 — QUANTIA A1-AT (May 13, 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)
  • K993444 — K-ASSAY ALPHA-1 AT (November 24, 1999)
  • K972640 — TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY (January 9, 1998)
  • K973392 — CHEMMATE LAMBDA (October 3, 1997)

FDA data resources