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510(k) K000934

MDI SCL-70 TEST by Micro Detect, Inc. — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2000
Date Received
March 23, 2000
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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  • K000477 — MDI DS-DNA TEST (March 1, 2000)
  • K993843 — MDI RF TEST (January 11, 2000)
  • K994029 — MDI SM TEST (January 11, 2000)
  • K993971 — MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN (January 11, 2000)
  • K993635 — MDI SM/RNP TEST (January 10, 2000)
  • K993636 — MDI SS-A TEST (January 10, 2000)
  • K973508 — PYLORI DETECT IGG (March 10, 1998)

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