Product code JJM

Device name: Osmometer For Clinical Use
Medical specialty: Clinical Chemistry
Device class: 1
Regulation number: 862.2730
Review panel: CH
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K965036	THE ADVANCED OSMOMETER (3900)	Advanced Instruments, Inc.	1997-02-20
K962056	ADVANCED MICRO-OSMOMETER MODEL 3300	Advanced Instruments, Inc.	1996-07-11
K925970	MODEL 3D3 OSMOMETER	Advanced Instruments, Inc.	1993-07-09
K911092	OSMOMETER MODEL 2400	Advanced Instruments, Inc.	1991-05-22
K873642	OSMOMETER MODEL 110	Advanced Instruments, Inc.	1987-10-20
K843997	AO-10 AUTOMATED OSMOMETER	bioMerieux, Inc.	1984-10-31
K842750	OSMOTIC PRESSURE AUTO & STAT OM-6010	Kyoto Diagnostics, Inc.	1984-08-17
K834214	WESCOR 5500 VAPOR PRESSURE OSMOMETER	Wescor, Inc.	1984-03-30
K834208	COLLOID OSMOMETER 4400	Wescor, Inc.	1984-03-23
K832783	MICRO-SAMPLE OSMOMETER 3M0	Advanced Instruments, Inc.	1983-11-28
K811179	OSMOMETER MODEL OM-6010	Fiske Med Science	1981-05-15
K790611	OSMOMETER MODEL 3W11	Advanced Instruments, Inc.	1979-06-15

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00850041049212	OSMETTE Sample Tubes, 2 ml, 12/pk	Precision Systems, Inc.	2023-10-14
00850041049434	Multi-OSMETTE Evaporation Shield	Precision Systems, Inc.	2023-10-14
00850041049427	Multi-OSMETTE Carousel, Spare	Precision Systems, Inc.	2023-10-14
00850041049410	OSMETTE Sample Tube Rack for 2.0 & 0.2 ml	Precision Systems, Inc.	2023-10-14
00850041049380	OSMETTE Sample Tubes, 30 ul	Precision Systems, Inc.	2023-10-14
00850041049373	OSMETTE III Plunger Tip Wire	Precision Systems, Inc.	2023-10-14
00850041049366	OSMETTE III 10 ul Pipet Piston 2/pk	Precision Systems, Inc.	2023-10-14
00850041049335	Micro-OSMETTE Stir Wires for 50 ul samples, 4/pkg	Precision Systems, Inc.	2023-10-14
00850041049328	OSMETTE Stir Wires, for 0.2 & 2.0 samples, 4/pkg	Precision Systems, Inc.	2023-10-14
00850041049311	CRYETTE Stir Wires, for 2 ml tubes, 4/pk	Precision Systems, Inc.	2023-10-14
00850041049281	Clearview Disp Sample Tubes, 0.2 ml	Precision Systems, Inc.	2023-10-14
00850041049267	OSMETTE Pipettor, 50 ul	Precision Systems, Inc.	2023-10-14
00850041049243	OSMETTE XL, 105VAC, Japan, special	Precision Systems, Inc.	2023-10-14
00850041049236	Micro-OSMETTE Sample Tubes, 50 ul	Precision Systems, Inc.	2023-10-14
00850041049229	OSMETTE Sample Tubes, 0.2 ml, 12/pk	Precision Systems, Inc.	2023-10-14
00850041049199	OSMETTE XL, 105VAC, Japan	Precision Systems, Inc.	2023-10-14
00850041049182	Multi-OSMETTE, Extended Range, 220V	Precision Systems, Inc.	2023-10-14
00850041049175	Probe for Multi-OSMETTE	Precision Systems, Inc.	2023-10-14
00850041049168	OSMETTE III with Barcode Reader, 220V	Precision Systems, Inc.	2023-10-14
00850041049144	Probe for Micro-OSMETTE	Precision Systems, Inc.	2023-10-14
00816068020504	Advanced Instruments Ease-Eject 20-Microliter Sampler	Advanced Instruments, LLC	2020-09-21
00816068020573	Advanced Instruments OsmoPRO Multi Sample Micro Osmometer Sample Tubes	Advanced Instruments, LLC	2020-09-21
10816068020600	Advanced Instruments A2O Advanced Automated Osmometer Samples Tubes, Box of 500	Advanced Instruments, LLC	2020-09-21
00816068020832	Advanced Instruments Model 3250 Single-Sample Osmometer Sample Tubes, Box of 500	Advanced Instruments, LLC	2020-09-21
00816068020658	Advanced Instruments Swab Cleaners	Advanced Instruments, LLC	2020-09-21
00816068020634	Advanced Instruments A2O System Fluid	Advanced Instruments, LLC	2020-09-21
00816068020627	Advanced Instruments Cuvettes	Advanced Instruments, LLC	2020-09-21
00816068020610	Advanced Instruments A2O Osmometer Probe Wiper Rings	Advanced Instruments, LLC	2020-09-21
00816068020597	Advanced Instruments 20 µL Pipet	Advanced Instruments, LLC	2020-09-21
00816068020580	Advanced Instruments 2020 Osmometer Probe Wiper Rings	Advanced Instruments, LLC	2020-09-21

Product code JJM

Related 510(k) Records#

Related GUDID Devices#