FASTPACK CONTROL KIT— 510(k) K123725
Substantially EquivalentQualigen, Inc.
FDA 510(k) clearance K123725 for FASTPACK CONTROL KIT, Substantially Equivalent on 2013-03-08. Applicant: Qualigen, Inc.. Device class: 1.
Clearance details
- Applicant
- Qualigen, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.