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510(k) K800820

AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY by Calbiochem-Behring Corp. — Product Code DBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1980
Date Received
April 11, 1980
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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  • K820088 — AFT SYSTEM PROFICIENCY TESTING PROGRAM (January 26, 1982)
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Other clearances for product code DBE

  • K810983 — ANTISMOOTH MUSCLE ANTIBODY TEST SYS (May 1, 1981)
  • 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)