510(k) K842750

Device: OSMOTIC PRESSURE AUTO & STAT OM-6010
Applicant: KYOTO DIAGNOSTICS, INC.
510(k) number: K842750
Product code: JJM
Decision: Substantially Equivalent (SESE)
Decision date: 1984-08-17
Date received: 1984-07-13
Regulation: 862.2730
Classification name: Osmometer For Clinical Use
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

3016648458
3008305513
3043138885
3030446844
3043088937
1217058
1250003
1717966
3009155756
3003591759
3027645317

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JJM #

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
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

Legacy Summary#

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