KAWASUMI LABORATORY BLOOD DRAWING KIT— 510(k) K001043
Substantially EquivalentKawasumi Laboratories America, Inc.
FDA 510(k) clearance K001043 for KAWASUMI LABORATORY BLOOD DRAWING KIT, Substantially Equivalent on 2000-05-19. Applicant: Kawasumi Laboratories America, Inc.. Device class: 2.
Clearance details
- Applicant
- Kawasumi Laboratories America, 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
- Tampa, FL, US
Recent devices under product code KSB
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- K030385 — IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR
- K001423 — KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
- K001424 — KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
- K001426 — KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
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