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510(k) K790759

IIF-APCA TEST KIT by Medica Corp. — Product Code DBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1979
Date Received
April 17, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5110
Review Panel
IM
Submission Type

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Other clearances for product code DBJ

  • K930422 — SYNELISA PARIETAL CELL ANTIBODIES (August 3, 1993)