NEONATAL BIOTINIDASE KIT, MODEL 3018— 510(k) K090123
Substantially EquivalentPerkinelmer, Inc.
FDA 510(k) clearance K090123 for NEONATAL BIOTINIDASE KIT, MODEL 3018, Substantially Equivalent on 2010-03-05. Applicant: Perkinelmer, Inc..
Clearance details
- Applicant
- Perkinelmer, Inc.
- Product code
- Code NAK
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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