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510(k) K843365

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

K843365 is an FDA 510(k) premarket notification submitted by Iso-Data, Inc. for the device "ISO-DATA IMMUNOASSAY NETWORK SYSTEM". The FDA issued a decision of Substantially Equivalent on September 27, 1984. The device falls under product code JQP (Calculator/Data Processing Module, For Clinical Use), a Class I device regulated under 21 CFR 862.2100. Iso-Data, Inc. has at least 6 other 510(k) clearances on record.

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.

  • K872430 — ISO-DATA 500 SERIES GAMMA COUNTER (August 21, 1987)
  • K872429 — ISO-DATA 100 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)

Other clearances for product code JQP

  • K113007 — BIONIME DIABETES MANAGEMENT SYSTEM VI.0 (February 27, 2012)
  • K983468 — FASTTAKE ADAPTER, MODEL # P/N 020-072-01 (December 17, 1998)
  • 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)

FDA data resources