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510(k) K832760

RIA SOFTWARE by Kemble Instruments, Inc. — Product Code JQP

K832760 is an FDA 510(k) premarket notification submitted by Kemble Instruments, Inc. for the device "RIA SOFTWARE". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code JQP (Calculator/Data Processing Module, For Clinical Use), a Class I device regulated under 21 CFR 862.2100. Kemble Instruments, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
August 19, 1983
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 Kemble Instruments, Inc.

  • K842894 — KEMBLE 405 (August 27, 1984)
  • K832734 — KEMTEK 400 RIA GAMMA COUNTER (October 14, 1983)
  • K832736 — KEMTEK 104 RIA GAMMA COUNTER (September 29, 1983)
  • K832735 — KEMTEK 103 RIA GAMMA COUNTER (September 29, 1983)
  • K830751 — KEMTEK 102 (April 6, 1983)
  • K822293 — IMMU-COUNT 404 (August 24, 1982)
  • K827748 — THYRO-COUNT THYROID UPTAKE SYSTEM 90IZD PROBE (August 16, 1982)
  • K820137 — IMMU-COUNT (February 5, 1982)

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