GSP NEONATAL TOTAL GALACTOSE KIT— 510(k) K133652
Substantially EquivalentWallac Oy, A Subsidiary of Perkinelmer, Inc.
FDA 510(k) clearance K133652 for GSP NEONATAL TOTAL GALACTOSE KIT, Substantially Equivalent on 2014-04-28. Applicant: Wallac Oy, A Subsidiary of Perkinelmer, Inc.. Device class: 1.
Clearance details
- Applicant
- Wallac Oy, A Subsidiary of Perkinelmer, Inc.
- Product code
- Code JIA
- Device class
- Class 1
- Regulation
- 21 CFR 862.1310
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
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More clearances from Wallac Oy, A Subsidiary of Perkinelmer, Inc.
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