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510(k) K982578

Device
QUANTI-TEST SYSTEM
Applicant
PANATREX, INC.
510(k) number
K982578
Product code
LDH  
Decision
Substantially Equivalent (SESE)
Decision date
1998-09-02
Date received
1998-07-23
Regulation
510(k) Premarket Notification
Classification name
System, Delivery, Allergen And Vaccine
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GREG HOLLAND
Address
3722 Ave. Sausalito Irvine CA US 92606 92606

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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