ADAMS A1c HA-8180V, CALIBRATOR 80— 510(k) K162822
Substantially EquivalentArkray Factory, Inc.
FDA 510(k) clearance K162822 for ADAMS A1c HA-8180V, CALIBRATOR 80, Substantially Equivalent on 2017-06-29. Applicant: Arkray Factory, Inc.. Device class: 2.
Clearance details
- Applicant
- Arkray Factory, Inc.
- Product code
- Code PDJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1373
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Koka-Shi, JP
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Data sourced from openFDA. This site is unofficial and independent of the FDA.