AUDIT MICROCV IMMUNOASSAY LINEARITY SET— 510(k) K062668
Substantially EquivalentAalto Scientific, Ltd.
FDA 510(k) clearance K062668 for AUDIT MICROCV IMMUNOASSAY LINEARITY SET, Substantially Equivalent on 2006-10-16. Applicant: Aalto Scientific, Ltd.. Device class: 1.
Clearance details
- Applicant
- Aalto Scientific, Ltd.
- 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.