SPIFE IFE CALIBRATOR AND CONTROL KIT— 510(k) K010617
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K010617 for SPIFE IFE CALIBRATOR AND CONTROL KIT, Substantially Equivalent on 2001-03-15. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code DEW
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
Recent devices under product code DEW
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Data sourced from openFDA. This site is unofficial and independent of the FDA.