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510(k) K952055

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

K952055 is an FDA 510(k) premarket notification submitted by American Laboratory Products Co., Ltd. for the device "ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY". The FDA issued a decision of Substantially Equivalent on July 18, 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. American Laboratory Products Co., Ltd. has at least 10 other 510(k) clearances on record.

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

Other clearances by American Laboratory Products Co., Ltd.

  • K012576 — CIC-C1Q EIA (January 29, 2002)
  • K011415 — ALPCO MILENIA ANTI-TG EIA (May 30, 2001)
  • K011201 — ALPCO MILENIA ANTI-TPO ELISA (May 24, 2001)
  • K974701 — ORGENTEC ANTI-MPO (P-ANCA) ELISA (February 17, 1998)
  • K974702 — ORGENTEC ANTI-PR3 (C-ANCA) ELISA (February 17, 1998)
  • K972190 — THYROGLOBULIN ASSAY SYSTEM (July 14, 1997)
  • K970932 — ORGENTEC MICRO-ALBUMIN EIA ASSAY (April 8, 1997)
  • K962057 — ORGENTEC ANTI-RNP/SM ELISA (November 18, 1996)
  • K962062 — ORGENTEC ANTI-SM ELISA (November 18, 1996)
  • K962055 — ORGENTEC ANTI-SCL 70 ELISA (November 15, 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