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510(k) K810631

DPM CALCULATOR by Iso-Data, Inc. — Product Code JQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1981
Date Received
March 10, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator/Data Processing Module, For Clinical Use
Device Class
Class I
Regulation Number
862.2100
Review Panel
CH
Submission Type

Other clearances by Iso-Data, Inc.

  • K872429 — ISO-DATA 100 SERIES GAMMA COUNTER (August 21, 1987)
  • K872430 — ISO-DATA 500 SERIES GAMMA COUNTER (August 21, 1987)
  • K843434 — ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. (October 5, 1984)
  • K843365 — ISO-DATA IMMUNOASSAY NETWORK SYSTEM (September 27, 1984)
  • K780813 — IDI GDR DATA REDUCTION SYSTEM (June 28, 1978)
  • K780790 — IDI 200 GAMMA COUNTER (June 22, 1978)

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