Home / 510(k) Clearances / K850587

510(k) K850587

SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN by Applications Lab — Product Code DEM

K850587 is an FDA 510(k) premarket notification submitted by Applications Lab for the device "SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN". The FDA issued a decision of Substantially Equivalent on March 14, 1985. The device falls under product code DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5130. Applications Lab has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1985
Date Received
February 13, 1985
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 Applications Lab

  • K850586 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M (March 14, 1985)
  • K850588 — SPQ TEST SYSTEM FOR COMPLEMENT C3 (March 5, 1985)
  • K850603 — SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN (March 5, 1985)
  • K850589 — SPQ TEST SYSTEM FOR TRANSFERRIN (March 5, 1985)
  • K850584 — SPQ TEST SYSTEM FOR HAPTOGLOBIN (March 5, 1985)
  • K850582 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A (March 1, 1985)
  • K850583 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G (March 1, 1985)
  • K850590 — SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN (March 1, 1985)
  • K850585 — SPQ TEST SYSTEM FOR COMPLEMENT C4 (March 1, 1985)

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)
  • 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)

FDA data resources