Kawasumi Laboratory Blood Drawing Kit
FDA 510(k) K001043 · Kawasumi Laboratories America, Inc.
510(k) numberK001043
Submission
- Device name
- Kawasumi Laboratory Blood Drawing Kit
- Applicant
- Kawasumi Laboratories America, Inc.
Tampa, FL, US - Received
- March 31, 2000
- Decision date
- May 19, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KSB – Set, Transfer (Blood/Plasma)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9875
- Specialty
- Hematology
Other 510(k)s with product code KSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKSB · Traditional | Kawasumi Laboratories, Inc. | 09/28/2018SE |
| K820447 | Alpha Plasma Transfer SetKSB · Traditional | Alpha Therapeutic Corp. | 04/14/1982SE |
| K802940 | Super-Spike Transfer SetKSB · Traditional | Geneva Laboratories, Inc. | 01/15/1981SE |
| K791131 | Flu Ven TR-1KSB · Traditional | Venospital, Inc. | 09/04/1979SE |
| K791130 | Flu-Ven TK-2KSB · Traditional | Venospital, Inc. | 09/04/1979SE |
More from Venospital, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102890 | K-Shield Small Vein Infusion / Winged Collection Set W/ Anti Needle Stick Protector (and…FPA · Special | 10/21/2010SE |
| K030385 | IV Add-On Filter Administration Set with and Without Y Connect or Needleless Access…FPA · Traditional | 04/15/2003SE |
| K001426 | Kawasumi Laboratories IV Administration Set with FilterFPA · Traditional | 07/21/2000SE |
| K001424 | Kawasumi Laboratories IV Administration Set, StandardFPA · Traditional | 07/21/2000SE |
| K001423 | Kawasumi Laboratories IV Administration Set, PrimaryFPA · Traditional | 07/21/2000SE |
Questions and answers
When was Kawasumi Laboratory Blood Drawing Kit cleared by the FDA?
Kawasumi Laboratory Blood Drawing Kit (K001043) received a 510(k) decision of Substantially Equivalent on May 19, 2000, 49 days after the submission was received.
What is the product code of K001043?
The FDA product code is KSB – Set, Transfer (Blood/Plasma), a Class II (moderate risk) device regulated under 21 CFR 864.9875.