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510(k) K831100

MEDICA IIF-MULTIPLE ANTIBODY TEST KIT by Medical Diagnostics, Ca. — Product Code DBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1983
Date Received
April 5, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5090
Review Panel
IM
Submission Type

Other clearances by Medical Diagnostics, Ca.

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  • K843343 — MEDICA IIF-ANTI-THYROID ANTIBODY TEST (October 22, 1984)

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