ALLERSHARP ALLERGY SKIN TESTER— 510(k) K011979
Substantially EquivalentHmb Medical Concepts, Ltd.
FDA 510(k) clearance K011979 for ALLERSHARP ALLERGY SKIN TESTER, Substantially Equivalent on 2001-09-14. Applicant: Hmb Medical Concepts, Ltd.. Device class: 2.
Clearance details
- Applicant
- Hmb Medical Concepts, Ltd.
- 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
- Alpharetta, GA, US
Recent devices under product code SCL
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- K172062 — AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray
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Data sourced from openFDA. This site is unofficial and independent of the FDA.