510(k) K042183

Device
GLUCOSE TOLERANCE BEVERAGE
Applicant
EVER SCIENTIFIC
510(k) number
K042183
Product code
MRV  
Decision
Substantially Equivalent (SESE)
Decision date
2004-10-27
Date received
2004-08-11
Regulation
862.1345
Classification name
Drink, Glucose Tolerance
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JAY REINHARDT
Address
7 Wetherill Ln. Chester Springs PA US 19425 19425

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MRV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K120247EASYDEXVineland Syrup, Inc.2012-06-21
K032753GLUCOSE TOLERANCE BEVERAGEPerk Scientific, Inc.2003-11-18

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