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510(k) K954814

ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY by Orgentec — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1996
Date Received
October 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Orgentec

  • K954830 — ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY (May 8, 1996)
  • K954831 — ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY (May 8, 1996)
  • K954829 — ORGENTEC ANTI-JO-1 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)
  • K960274 — ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY (March 29, 1996)
  • K955134 — ORGENTEC ENASCREEN ELISA ASSAY (March 20, 1996)
  • K955133 — ORGENTEC ENASCREEN PIN IMMUNO ASSAY (March 20, 1996)
  • K953671 — ORGEN TEC ANTI-DSDNA ELISA ASSAY (November 9, 1995)

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