Kawasumi Laboratories Blood Drawing Kit (BDK) System
FDA 510(k) clearance K172957 · decided 2018-09-28
Clearance details
- K-number
- K172957
- Device name
- Kawasumi Laboratories Blood Drawing Kit (BDK) System
- Applicant
- Kawasumi Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-26
- Decision date
- 2018-09-28
- Days to decision
- 367 days
- Clearance type
- Traditional
- Product code
- KSB
- Device class
- 2
- Regulation number
- 864.9875
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KAWASUMI LABORATORY BLOOD DRAWING KIT (K001043) | Kawasumi Laboratories America, Inc. | 2000-05-19 |
| ALPHA PLASMA TRANSFER SET (K820447) | Alpha Therapeutic Corp. | 1982-04-14 |
| SUPER-SPIKE TRANSFER SET (K802940) | Geneva Laboratories, Inc. | 1981-01-15 |
| FLU-VEN TK-2 (K791130) | Venospital, Inc. | 1979-09-04 |
| FLU VEN TR-1 (K791131) | Venospital, Inc. | 1979-09-04 |
Recalls involving this device
No recalls on record reference this clearance.