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510(k) K850586

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M by Applications Lab — Product Code DAO

K850586 is an FDA 510(k) premarket notification submitted by Applications Lab for the device "SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M". The FDA issued a decision of Substantially Equivalent on March 14, 1985. The device falls under product code DAO (Igm (Mu Chain Specific), Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Applications Lab has at least 9 other 510(k) clearances on record.

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
Igm (Mu Chain Specific), Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

Other clearances by Applications Lab

  • K850587 — SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN (March 14, 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)
  • K850589 — SPQ TEST SYSTEM FOR TRANSFERRIN (March 5, 1985)
  • K850585 — SPQ TEST SYSTEM FOR COMPLEMENT C4 (March 1, 1985)
  • K850583 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G (March 1, 1985)
  • K850590 — SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN (March 1, 1985)
  • K850582 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A (March 1, 1985)

Other clearances for product code DAO

  • K040431 — ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 (March 10, 2004)
  • K982639 — SPIFE URINE IFE (November 4, 1998)
  • K955908 — BOEHRINGER MANNHEIM IGM ASSAY (February 9, 1996)
  • K841992 — MODIFICATION TO ACS CORONARY GUIDING (June 11, 1984)
  • K812487 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM (September 23, 1981)
  • K800450 — GEMENI IGM ASSAY (April 24, 1980)
  • K790705 — ANTISERUM TO HUMAN IGM (April 12, 1979)

FDA data resources