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510(k) K850585

SPQ TEST SYSTEM FOR COMPLEMENT C4 by Applications Lab — Product Code DBI

K850585 is an FDA 510(k) premarket notification submitted by Applications Lab for the device "SPQ TEST SYSTEM FOR COMPLEMENT C4". The FDA issued a decision of Substantially Equivalent on March 1, 1985. The device falls under product code DBI (Complement C4, 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 1, 1985
Date Received
February 13, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C4, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
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)
  • K850603 — SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN (March 5, 1985)
  • K850584 — SPQ TEST SYSTEM FOR HAPTOGLOBIN (March 5, 1985)
  • K850582 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A (March 1, 1985)
  • K850590 — SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN (March 1, 1985)
  • K850583 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G (March 1, 1985)

Other clearances for product code DBI

  • K100455 — SPAPLUS ANALYZER (September 3, 2010)
  • K012359 — TINA-QUANT COMPLEMENT C4 TEST SYSTEM (November 29, 2001)
  • K010325 — WAKO AUTOKIT C4 (June 25, 2001)
  • K000468 — RANDOX COMPLEMENT C4 (March 27, 2000)
  • K994293 — DIMENSION C4 FLEX REAGENT CARTRIDGE (March 1, 2000)
  • K981785 — C4 MININEPH ANTISERUM (December 20, 1999)
  • K993481 — K-ASSAY C4 (November 29, 1999)
  • K983356 — C4 (November 4, 1998)
  • K964297 — N-ASSAY TIA C4 TEST KIT (July 14, 1997)
  • K964300 — N-ASSAY TIA MULTI V-NL (July 14, 1997)

FDA data resources