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510(k) K843434

ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. by Iso-Data, Inc. — Product Code JQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1984
Date Received
September 4, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device Class
Class I
Regulation Number
862.2050
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)
  • K843365 — ISO-DATA IMMUNOASSAY NETWORK SYSTEM (September 27, 1984)
  • K810631 — DPM CALCULATOR (March 27, 1981)
  • K780813 — IDI GDR DATA REDUCTION SYSTEM (June 28, 1978)
  • K780790 — IDI 200 GAMMA COUNTER (June 22, 1978)

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