FDA.reportPublic FDA data

510(k) K850858

Device
OB-PH - PH TEST PAPER
Applicant
URO PHARMACEUTICALS, INC.
510(k) number
K850858
Product code
LNW  
Decision
Substantially Equivalent (SESE)
Decision date
1985-05-24
Date received
1985-03-01
Regulation
862.1550
Classification name
Paper, Obstetric Ph
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
NICHOLAS D ROTELLO
Address
P.O. Box 2073 Port Angeles WA US 98362 98362

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K960648PHEM-CHEKFemtek, Inc.1996-05-13

Legacy Summary#

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

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