Kawasumi Laboratories Blood Drawing Kit (BDK) System— 510(k) K172957
Substantially EquivalentKawasumi Laboratories, Inc.
FDA 510(k) clearance K172957 for Kawasumi Laboratories Blood Drawing Kit (BDK) System, Substantially Equivalent on 2018-09-28. Applicant: Kawasumi Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Kawasumi Laboratories, Inc.
- Product code
- Code KSB
- Device class
- Class 2
- Regulation
- 21 CFR 864.9875
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
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