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510(k) K952055

ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY by American Laboratory Products Co., Ltd. — Product Code LRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1995
Date Received
May 2, 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

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Other clearances for product code LRM

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  • 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)
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  • 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)