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510(k) K993971

MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM by Micro Detect, Inc. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2000
Date Received
November 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractable Antinuclear Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Micro Detect, Inc.

  • K003794 — ELISA TEST, SEROLOGY (March 30, 2001)
  • 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)
  • K993843 — MDI RF TEST (January 11, 2000)
  • K994029 — MDI SM TEST (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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