SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT— 510(k) K102643
Substantially EquivalentAstoria-Pacific, Inc.
FDA 510(k) clearance K102643 for SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT, Substantially Equivalent on 2011-07-15. Applicant: Astoria-Pacific, Inc.. Device class: 2.
Clearance details
- Applicant
- Astoria-Pacific, Inc.
- Product code
- Code KQP
- Device class
- Class 2
- Regulation
- 21 CFR 862.1315
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clackamas, OR, US
Recent devices under product code KQP
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Data sourced from openFDA. This site is unofficial and independent of the FDA.