Ria Software

FDA 510(k) K832760 · Kemble Instruments, Inc.

Substantially Equivalent

510(k) numberK832760

Submission

Device name
Ria Software
Applicant
Kemble Instruments, Inc.
Mchenry, IL, US
Received
August 19, 1983
Decision date
October 14, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JQP – Calculator/Data Processing Module, For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2100
Specialty
Clinical Chemistry

Other 510(k)s with product code JQP

510(k)DeviceApplicantDecision
K113007Bionime Diabetes Management System VI.0JQP · Traditional Bionime Corporation02/27/2012SE
K983468Fasttake Adapter, Model # P/N 020-072-01JQP · Traditional Selfcare, Inc.12/17/1998SE
K964460The RoboliteJQP · Traditional Shai Syg Motion and Innovations, Ltd.01/24/1997SE
K953652Prenval IJQP · Traditional Base Ten Systems, Inc.09/15/1995SE
K934111MR7000 with Time Manager Software (TMS)JQP · Traditional Dynatech Laboratories, Inc.11/02/1994SE
K923316Expresso CartridgeJQP · Traditional Bio-Rad Laboratories, Inc.02/23/1993SE
K893838Modified Model 570 Clinical Chemistry AnalyzerJQP · Traditional Ciba Corning Diagnostics Corp.08/31/1989SE
K892060Cyberlab High Volume Drug Testing SystemJQP · Traditional Syva Co.08/10/1989SE
K885292Cobas MFCJQP · Traditional Roche Diagnostic Systems, Inc.03/22/1989SE
K881194Ria-QuickJQP · Traditional Quantitative Technologies, Inc.06/01/1988SE

More from Quantitative Technologies, Inc.

510(k)DeviceDecision
K842894Kemble 405JQW · Traditional 08/27/1984SE
K832734Kemtek 400 Ria Gamma CounterJJJ · Traditional 10/14/1983SE
K832736Kemtek 104 Ria Gamma CounterJJJ · Traditional 09/29/1983SE
K832735Kemtek 103 Ria Gamma CounterJJJ · Traditional 09/29/1983SE
K830751Kemtek 102JJJ · Traditional 04/06/1983SE
K822293Immu-Count 404JJJ · Traditional 08/24/1982SE
K827748Thyro-Count Thyroid Uptake System 90IZD Probe · Traditional 08/16/1982SE
K820137Immu-CountJJJ · Traditional 02/05/1982SE

Questions and answers

When was Ria Software cleared by the FDA?

Ria Software (K832760) received a 510(k) decision of Substantially Equivalent on October 14, 1983, 56 days after the submission was received.

What is the product code of K832760?

The FDA product code is JQP – Calculator/Data Processing Module, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2100.