DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D— 510(k) K000299
Substantially EquivalentBiomedex, Inc.
FDA 510(k) clearance K000299 for DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D, Substantially Equivalent on 2000-04-28. Applicant: Biomedex, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomedex, Inc.
- Product code
- Code SCL
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, OR, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.