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510(k) K843343

MEDICA IIF-ANTI-THYROID ANTIBODY TEST by Medical Diagnostics, Ca. — Product Code JZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1984
Date Received
August 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Thyroid Autoantibody
Device Class
Class II
Regulation Number
866.5870
Review Panel
IM
Submission Type

Other clearances by Medical Diagnostics, Ca.

  • K853140 — MDI QUIK TEST NARCOTICS DRUG SCREEN (March 3, 1986)
  • K843900 — FOCUSCOPE UNIVERSAL SYSTEM (December 6, 1984)
  • K831100 — MEDICA IIF-MULTIPLE ANTIBODY TEST KIT (May 4, 1983)

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  • K083391 — THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY (May 21, 2009)