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510(k) K012230

Device
PHEM-ALERT
Applicant
FEMTEK,LLC.
510(k) number
K012230
Product code
LNW  
Decision
Substantially Equivalent (SESE)
Decision date
2001-10-09
Date received
2001-07-16
Regulation
862.1550
Classification name
Paper, Obstetric Ph
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOEL S FADEN
Address
11605 Hitching Post Ln. Rockville MD US 20852 20852

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LNW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K032161PHEM-ALERTFemtek,Llc.2003-09-30
K960648PHEM-CHEKFemtek, Inc.1996-05-13
K850858OB-PH - PH TEST PAPERUro Pharmaceuticals, Inc.1985-05-24

Legacy Summary#

summary

FDA Review#

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