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510(k) K953671

ORGEN TEC ANTI-DSDNA ELISA ASSAY by Orgentec — Product Code LRM

K953671 is an FDA 510(k) premarket notification submitted by Orgentec for the device "ORGEN TEC ANTI-DSDNA ELISA ASSAY". The FDA issued a decision of Substantially Equivalent on November 9, 1995. The device falls under product code LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Orgentec has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1995
Date Received
August 7, 1995
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 Orgentec

  • K954831 — ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY (May 8, 1996)
  • K954830 — ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY (May 8, 1996)
  • K954814 — ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY (April 18, 1996)
  • K954832 — ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY (April 18, 1996)
  • K954815 — ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY (April 18, 1996)
  • K954829 — ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY (April 18, 1996)
  • K960274 — ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY (March 29, 1996)
  • K955133 — ORGENTEC ENASCREEN PIN IMMUNO ASSAY (March 20, 1996)
  • K955134 — ORGENTEC ENASCREEN ELISA ASSAY (March 20, 1996)

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