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510(k) K850587

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

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

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  • K993444 — K-ASSAY ALPHA-1 AT (November 24, 1999)
  • K972640 — TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY (January 9, 1998)