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.. Device class: 2.
Clearance details
- Applicant
- Perkinelmer, Inc.
- Product code
- Code NAK
- Device class
- Class 2
- Regulation
- 21 CFR 862.1118
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code NAK
view allMore clearances from Perkinelmer, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.