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510(k) K943466

Device
MINI S.F.T. (URINE PRESERVATIVE)
Applicant
CAMBRIDGE DIAGNOSTIC PRODUCTS, INC.
510(k) number
K943466
Product code
LXG  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-24
Date received
1994-06-15
Regulation
862.2050
Classification name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical 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
JACK H GOLD
Address
6880 NW 17th Ave. Ft. Lauderdale FL US 33309 33309

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LXG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K021927PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEMBiomet, Inc.2002-07-12
K896802MAGNET PADWestmark, Sterile Packing Systems, Inc. (Sps)1989-12-27

Legacy Summary#

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FDA Review#

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