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510(k) K810983

ANTISMOOTH MUSCLE ANTIBODY TEST SYS by Immuno-Products Industries — Product Code DBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1981
Date Received
April 13, 1981
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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  • K831054 — ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB (April 27, 1983)
  • K830652 — ANTI N DNA-HCP (March 24, 1983)
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  • K810982 — ANTITHYROID ANTIBODY IMMUNOFLUORESCENT (May 1, 1981)
  • K810985 — ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT (May 1, 1981)
  • K810984 — ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST (May 1, 1981)

Other clearances for product code DBE

  • K800820 — AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY (April 24, 1980)
  • K800228 — IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT (February 21, 1980)
  • K790430 — MEDICA II-F-ASMA TEST KIT (April 23, 1979)
  • K771155 — ANTI-MITOCHONDRIAL (August 4, 1977)
  • K760156 — TEST, (IVDP) SMOOTHMUSCLE ANTIBODY (July 20, 1976)