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510(k) K000299

Device
DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D
Applicant
BIOMEDEX, INC.
510(k) number
K000299
Product code
LDH  
Decision
Substantially Equivalent (SESE)
Decision date
2000-04-28
Date received
2000-01-31
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
JAMES L THOMPSON
Address
3380 Mistletoe Rd. Dallas OR US 97338 97338

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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