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510(k) K923537

ENCORE DS-DNA by Clark Laboratories, Inc. — Product Code LRM

K923537 is an FDA 510(k) premarket notification submitted by Clark Laboratories, Inc. for the device "ENCORE DS-DNA". The FDA issued a decision of Substantially Equivalent on December 23, 1992. The device falls under product code LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Clark Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1992
Date Received
July 16, 1992
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 Clark Laboratories, Inc.

  • K980912 — VCA IGG ELISA TEST SYSTEM (July 22, 1998)
  • K980596 — VCA IGM ELISA TEST SYSTEM (July 22, 1998)
  • K980598 — EBNA-1 IGM ELISA TEST SYSTEM (May 1, 1998)
  • K973123 — EA-D IGG ELISA TEST SYSTEM (March 26, 1998)
  • K931543 — ENCORE ENA COMBINED EIA (September 8, 1993)
  • K925826 — ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA (January 26, 1993)
  • K921870 — ENCORE SM/RNP (December 1, 1992)
  • K921572 — ENCORE SM (December 1, 1992)
  • K922340 — ENCORE SS-B (October 16, 1992)
  • K922157 — ENCORE SS-A (October 13, 1992)

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