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510(k) K850603

SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN by Applications Lab — Product Code DEB

K850603 is an FDA 510(k) premarket notification submitted by Applications Lab for the device "SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN". The FDA issued a decision of Substantially Equivalent on March 5, 1985. The device falls under product code DEB (Alpha-2-Macroglobulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5620. Applications Lab has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1985
Date Received
February 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5620
Review Panel
IM
Submission Type

Other clearances by Applications Lab

  • K850587 — SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN (March 14, 1985)
  • K850586 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M (March 14, 1985)
  • K850589 — SPQ TEST SYSTEM FOR TRANSFERRIN (March 5, 1985)
  • K850588 — SPQ TEST SYSTEM FOR COMPLEMENT C3 (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)
  • K850585 — SPQ TEST SYSTEM FOR COMPLEMENT C4 (March 1, 1985)
  • K850590 — SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN (March 1, 1985)

Other clearances for product code DEB

  • K140664 — HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS (April 16, 2014)
  • K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT (July 21, 2008)
  • K053073 — N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN (March 28, 2006)
  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (February 17, 1998)
  • K914389 — ALPHA-2 MACROGLOBULIN TEST RID KIT (December 20, 1991)
  • K896483 — QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK (December 1, 1989)
  • K850683 — 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 (November 27, 1985)
  • K851282 — RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI (May 24, 1985)
  • K812493 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO (September 23, 1981)
  • K791340 — HUMAN ALPHA2 MACROGLOBULIN (August 16, 1979)

FDA data resources