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510(k) K850583

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G by Applications Lab — Product Code DEW

K850583 is an FDA 510(k) premarket notification submitted by Applications Lab for the device "SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G". The FDA issued a decision of Substantially Equivalent on March 1, 1985. The device falls under product code DEW (Igg, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Applications Lab has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1985
Date Received
February 13, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
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)
  • K850589 — SPQ TEST SYSTEM FOR TRANSFERRIN (March 5, 1985)
  • K850603 — SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN (March 5, 1985)
  • K850588 — SPQ TEST SYSTEM FOR COMPLEMENT C3 (March 5, 1985)
  • K850584 — SPQ TEST SYSTEM FOR HAPTOGLOBIN (March 5, 1985)
  • K850590 — SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN (March 1, 1985)
  • K850585 — SPQ TEST SYSTEM FOR COMPLEMENT C4 (March 1, 1985)
  • K850582 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A (March 1, 1985)

Other clearances for product code DEW

  • K050113 — TINA-QUANT IGG GEN.2 (February 8, 2005)
  • K040434 — ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (March 10, 2004)
  • K010617 — SPIFE IFE CALIBRATOR AND CONTROL KIT (March 15, 2001)
  • K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (January 18, 2000)
  • K993281 — K-ASSAY IGG (November 9, 1999)
  • K983221 — IGG (November 4, 1998)
  • K965108 — SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (March 6, 1997)
  • K963974 — IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (March 6, 1997)
  • K963868 — IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (February 10, 1997)
  • K962202 — QUANTEX IGG (September 26, 1996)

FDA data resources