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510(k) K850584

SPQ TEST SYSTEM FOR HAPTOGLOBIN by Applications Lab — Product Code DAD

K850584 is an FDA 510(k) premarket notification submitted by Applications Lab for the device "SPQ TEST SYSTEM FOR HAPTOGLOBIN". The FDA issued a decision of Substantially Equivalent on March 5, 1985. The device falls under product code DAD (Haptoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5460. 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
Haptoglobin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5460
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)
  • K850583 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G (March 1, 1985)
  • K850582 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A (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 DAD

  • K993480 — K-ASSAY HAPTOGLOBIN (November 24, 1999)
  • K972639 — TINA-QUANT HAPTOGLOBIN (January 9, 1998)
  • K964301 — N-ASSAY TIA MULTI V-NL (July 14, 1997)
  • K963286 — IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT (October 7, 1996)
  • K952593 — N/T PROTEIN CONTROL SY/L, M AND H (July 17, 1995)
  • K915829 — IL TEST(TM) HAPTOGLOBIN (HPT) (July 29, 1992)
  • K911898 — RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT (May 8, 1991)
  • K890562 — SPQ(TM) ANTIBODY REAGENT SET II FOR HPT (February 22, 1989)
  • K873866 — HAPTOGLOBIN (October 20, 1987)
  • K872717 — QM300 HAPTOGLOBIN ANTIBODY PACK (July 21, 1987)

FDA data resources