510(k) K961515— QUANTASE PHENYLALANINE ASSAY
Substantially EquivalentShield Diagnostics, Ltd.
Clearance details
- Applicant
- Shield Diagnostics, Ltd.
- Product code
- Code JNB
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dundee, GB
Data sourced from openFDA. This site is unofficial and independent of the FDA.