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510(k) K001900

ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST by Helix Diagnostics, Inc. — Product Code LRM

K001900 is an FDA 510(k) premarket notification submitted by Helix Diagnostics, Inc. for the device "ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST". The FDA issued a decision of Substantially Equivalent on September 11, 2000. The device falls under product code LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Helix Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2000
Date Received
June 22, 2000
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 Helix Diagnostics, Inc.

  • K000489 — ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST (April 5, 2000)
  • K980337 — DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM (May 12, 1998)
  • K960091 — ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT (March 20, 1996)
  • K954723 — ENZYME IMMUNOASSAY ANA SCREENING TEST KIT (December 15, 1995)
  • K954700 — ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT (December 15, 1995)
  • K952253 — ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT (August 24, 1995)
  • K951850 — ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT (July 18, 1995)
  • K951798 — ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT (July 17, 1995)
  • K940510 — ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT (April 20, 1994)
  • K940588 — ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT (April 20, 1994)

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)
  • 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)
  • K980391 — SERAQUEST ANTI-DSDNA (April 24, 1998)

FDA data resources