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510(k) K032753

Device
GLUCOSE TOLERANCE BEVERAGE
Applicant
PERK SCIENTIFIC, INC.
510(k) number
K032753
Product code
MRV  
Decision
Substantially Equivalent (SESE)
Decision date
2003-11-18
Date received
2003-09-05
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
MARK BARTOSH
Address
520 Commerce Dr. Yeadon PA US 19050 19050

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
K042183GLUCOSE TOLERANCE BEVERAGEEver Scientific2004-10-27

Legacy Summary#

summary

FDA Review#

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