Prenval I

FDA 510(k) K953652 · Base Ten Systems, Inc.

Substantially Equivalent

510(k) numberK953652

Submission

Device name
Prenval I
Applicant
Base Ten Systems, Inc.
Trenton, NJ, US
Received
August 7, 1995
Decision date
September 15, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
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
K871853V-Marc 88A ComputerJQP · Traditional V.Marc, A Div. of Pictorial, Inc.07/16/1987SE

More from V.Marc, A Div. of Pictorial, Inc.

510(k)DeviceDecision
K961160Upacs Version 1.7LMB · Traditional 06/11/1996SE
K960941UpacsLMB · Traditional 06/03/1996SE

Questions and answers

When was Prenval I cleared by the FDA?

Prenval I (K953652) received a 510(k) decision of Substantially Equivalent on September 15, 1995, 39 days after the submission was received.

What is the product code of K953652?

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.