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510(k) K850588

SPQ TEST SYSTEM FOR COMPLEMENT C3 by Applications Lab — Product Code CZW

K850588 is an FDA 510(k) premarket notification submitted by Applications Lab for the device "SPQ TEST SYSTEM FOR COMPLEMENT C3". The FDA issued a decision of Substantially Equivalent on March 5, 1985. The device falls under product code CZW (Complement C3, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. 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 13, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C3, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

Other clearances by Applications Lab

  • K850586 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M (March 14, 1985)
  • K850587 — SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN (March 14, 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 CZW

  • K100179 — SPAPLUS (August 13, 2010)
  • K063150 — COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL (March 19, 2007)
  • K061852 — DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL (September 22, 2006)
  • K050665 — N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) (May 2, 2005)
  • K042494 — VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMA (October 19, 2004)
  • K032796 — IBL C3D-CIC EIA TEST (January 13, 2004)
  • K032035 — SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C (August 7, 2003)
  • K012361 — TINA-QUANT COMPLEMENT C3C TEST SYSTEM (November 29, 2001)
  • K010326 — WAKO AUTOKIT C3 (June 25, 2001)
  • K000469 — RANDOX COMPLEMENT C3 (March 27, 2000)

FDA data resources