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510(k) K790430

MEDICA II-F-ASMA TEST KIT by Medica Corp. — Product Code DBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1979
Date Received
March 2, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5120
Review Panel
IM
Submission Type

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Other clearances for product code DBE

  • K810983 — ANTISMOOTH MUSCLE ANTIBODY TEST SYS (May 1, 1981)
  • K800820 — AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY (April 24, 1980)
  • K800228 — IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT (February 21, 1980)
  • K771155 — ANTI-MITOCHONDRIAL (August 4, 1977)
  • K760156 — TEST, (IVDP) SMOOTHMUSCLE ANTIBODY (July 20, 1976)