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510(k) K960182

DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM by Mardx Diagnostics, Inc. — Product Code LRM

K960182 is an FDA 510(k) premarket notification submitted by Mardx Diagnostics, Inc. for the device "DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on March 20, 1996. The device falls under product code LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Mardx Diagnostics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1996
Date Received
January 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Mardx Diagnostics, Inc.

  • K964787 — MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM (April 8, 1997)
  • K951709 — MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM (June 7, 1996)
  • K950829 — MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM (June 5, 1996)
  • K894224 — MARDX LYME DISEASE EIA (IGG) TEST SYSTEM (August 21, 1989)
  • K894293 — MARDX LYME DISEASE EIA (IGM) TEST SYSTEM (August 21, 1989)
  • K892206 — MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM (August 15, 1989)
  • K890053 — MARDX LYME DISEASE IGG IFA TEST SYSTEM (April 18, 1989)

Other clearances for product code LRM

  • K101319 — IMMULISA DSDNA ANTIBODY ELISA (December 9, 2010)
  • K083381 — EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) (April 15, 2009)
  • K062183 — FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT (November 21, 2006)
  • K040811 — VARELISA SSDNA ANTIBODIES, MODEL 14896 (May 13, 2004)
  • K001900 — ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST (September 11, 2000)
  • K000477 — MDI DS-DNA TEST (March 1, 2000)
  • K994424 — DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM (February 18, 2000)
  • K993727 — BINDAZYME ANTI-DSDNA EIA KIT (December 21, 1999)
  • K984396 — LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 (December 18, 1998)
  • K983422 — THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUN (November 18, 1998)

FDA data resources