FDA.reportPublic FDA data

510(k) K960648

Device
PHEM-CHEK
Applicant
FEMTEK, INC.
510(k) number
K960648
Product code
LNW  
Decision
Substantially Equivalent (SESE)
Decision date
1996-05-13
Date received
1996-02-14
Regulation
862.1550
Classification name
Paper, Obstetric Ph
Medical specialty
Clinical Chemistry
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JAMES C CAILLOUETTE, MD
Address
50 Bellefontaine St. Pasadena CA US 91105 91105

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
K012230PHEM-ALERTFemtek,Llc.2001-10-09
K850858OB-PH - PH TEST PAPERUro Pharmaceuticals, Inc.1985-05-24

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases