GenetiSure Dx Postnatal Assay— 510(k) K163367
Substantially EquivalentAgilent Technologies, Inc.
FDA 510(k) clearance K163367 for GenetiSure Dx Postnatal Assay, Substantially Equivalent on 2017-08-11. Applicant: Agilent Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Agilent Technologies, Inc.
- Product code
- Code PFX
- Device class
- Class 2
- Regulation
- 21 CFR 866.5920
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
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Recalls naming K163367
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163367.
Data sourced from openFDA. This site is unofficial and independent of the FDA.