AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument— 510(k) K163274
Substantially EquivalentAggredyne, Inc.
FDA 510(k) clearance K163274 for AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument, Substantially Equivalent on 2017-04-05. Applicant: Aggredyne, Inc.. Device class: 2.
Clearance details
- Applicant
- Aggredyne, Inc.
- Product code
- Code JOZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5700
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Houston, TX, US
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More clearances from Aggredyne, Inc.
view allRecalls naming K163274
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 K163274.
Data sourced from openFDA. This site is unofficial and independent of the FDA.