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510(k) K993635

MDI SM/RNP TEST by Micro Detect, Inc. — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2000
Date Received
October 27, 1999
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 Micro Detect, Inc.

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  • K002358 — MDI GLIADIN A TEST (October 19, 2000)
  • K002359 — MDI GLIADIN G TEST (October 19, 2000)
  • K000934 — MDI SCL-70 TEST (April 7, 2000)
  • K000477 — MDI DS-DNA TEST (March 1, 2000)
  • K993971 — MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN (January 11, 2000)
  • K994029 — MDI SM TEST (January 11, 2000)
  • K993843 — MDI RF TEST (January 11, 2000)
  • K993636 — MDI SS-A TEST (January 10, 2000)
  • K973508 — PYLORI DETECT IGG (March 10, 1998)

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