510(k) K003195
- Device
- GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC
- Applicant
- GREER LABORATORIES, INC.
- 510(k) number
- K003195
- Product code
- LDH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-12-13
- Date received
- 2000-10-12
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GERALD FRIESEN
- Address
- 639 Nuway Cir., NE P.O. Box 800 Lenoir NC US 28645 28645
FDA Registration Numbers#
- 1011574
- 1047843
- 3007590959
- 1061927
- 3030554525
- 3010132111
- 1928237
- 3011088743
- 3002807310
- 1450391
- 1055876
- 3012620142
- 3017896194
- 2531321
- 1424263
- 3014290918
- 3008812251
- 8043734
- 2248704
- 3010131789
- 3015536286
- 3009449769
- 1423507
Source Documents#
Legacy Summary#
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FDA Review#
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