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510(k) K965036

Device
THE ADVANCED OSMOMETER (3900)
Applicant
ADVANCED INSTRUMENTS, INC.
510(k) number
K965036
Product code
JJM  
Decision
Substantially Equivalent (SESE)
Decision date
1997-02-20
Date received
1996-12-17
Regulation
862.2730
Classification name
Osmometer For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DOUGLAS GUERETTE
Address
Two Technology Way Norwood MA US 02062 02062

FDA Registration Numbers#

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)DeviceApplicantDecision date
K962056ADVANCED MICRO-OSMOMETER MODEL 3300Advanced Instruments, Inc.1996-07-11
K925970MODEL 3D3 OSMOMETERAdvanced Instruments, Inc.1993-07-09
K911092OSMOMETER MODEL 2400Advanced Instruments, Inc.1991-05-22
K873642OSMOMETER MODEL 110Advanced Instruments, Inc.1987-10-20
K843997AO-10 AUTOMATED OSMOMETERbioMerieux, Inc.1984-10-31
K842750OSMOTIC PRESSURE AUTO & STAT OM-6010Kyoto Diagnostics, Inc.1984-08-17
K834214WESCOR 5500 VAPOR PRESSURE OSMOMETERWescor, Inc.1984-03-30
K834208COLLOID OSMOMETER 4400Wescor, Inc.1984-03-23
K832783MICRO-SAMPLE OSMOMETER 3M0Advanced Instruments, Inc.1983-11-28
K811179OSMOMETER MODEL OM-6010Fiske Med Science1981-05-15
K790611OSMOMETER MODEL 3W11Advanced Instruments, Inc.1979-06-15

Legacy Summary#

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FDA Review#

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