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510(k) K843365

ISO-DATA IMMUNOASSAY NETWORK SYSTEM by Iso-Data, Inc. — Product Code JQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1984
Date Received
August 28, 1984
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)
  • 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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  • K964460 — THE ROBOLITE (January 24, 1997)
  • K953652 — PRENVAL I (September 15, 1995)
  • K934111 — MR7000 WITH TIME MANAGER SOFTWARE (TMS) (November 2, 1994)
  • K923316 — EXPRESSO CARTRIDGE (February 23, 1993)
  • K893838 — MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER (August 31, 1989)
  • K892060 — CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM (August 10, 1989)
  • K885292 — COBAS MFC (March 22, 1989)
  • K881194 — RIA-QUICK (June 1, 1988)