Model 3D3 Osmometer

FDA 510(k) K925970 · Advanced Instruments, Inc.

Substantially Equivalent

510(k) numberK925970

Submission

Device name
Model 3D3 Osmometer
Applicant
Advanced Instruments, Inc.
Norwood, MA, US
Received
November 25, 1992
Decision date
July 9, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JJM – Osmometer For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2730
Specialty
Clinical Chemistry

Other 510(k)s with product code JJM

510(k)DeviceApplicantDecision
K965036The Advanced Osmometer (3900)JJM · Traditional Advanced Instruments, Inc.02/20/1997SE
K962056Advanced Micro-Osmometer Model 3300JJM · Traditional Advanced Instruments, Inc.07/11/1996SE
K911092Osmometer Model 2400JJM · Traditional Advanced Instruments, Inc.05/22/1991SE
K873642Osmometer Model 110JJM · Traditional Advanced Instruments, Inc.10/20/1987SE
K843997AO-10 Automated OsmometerJJM · Traditional bioMerieux, Inc.10/31/1984SE
K842750Osmotic Pressure Auto & Stat OM-6010JJM · Traditional Kyoto Diagnostics, Inc.08/17/1984SE
K834214Wescor 5500 Vapor Pressure OsmometerJJM · Traditional Wescor, Inc.03/30/1984SE
K834208Colloid Osmometer 4400JJM · Traditional Wescor, Inc.03/23/1984SE
K832783Micro-Sample Osmometer 3M0JJM · Traditional Advanced Instruments, Inc.11/28/1983SE
K811179Osmometer Model OM-6010JJM · Traditional Fiske Med Science05/15/1981SE

More from Fiske Med Science

510(k)DeviceDecision
K152776Glocyte Automated Cell Counter SystemGKL · Traditional 05/27/2016SE
K120631Patient MonitorMHX · Traditional 05/25/2012SE
K112465Vital Signs MonitorDQA · Traditional 09/14/2011SE
K965036The Advanced Osmometer (3900)JJM · Traditional 02/20/1997SE
K962056Advanced Micro-Osmometer Model 3300JJM · Traditional 07/11/1996SE
K930526Intermittent Compression System Model 5000JOW · Traditional 11/18/1993SE
K911092Osmometer Model 2400JJM · Traditional 05/22/1991SE
K873642Osmometer Model 110JJM · Traditional 10/20/1987SE
K863516Electronic Metal Locator Model MD-1 · Traditional 09/30/1986SE
K842784CeregrotracGWQ · Traditional 01/10/1985SE

Questions and answers

When was Model 3D3 Osmometer cleared by the FDA?

Model 3D3 Osmometer (K925970) received a 510(k) decision of Substantially Equivalent on July 9, 1993, 226 days after the submission was received.

What is the product code of K925970?

The FDA product code is JJM – Osmometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2730.