Alpha Plasma Transfer Set
FDA 510(k) K820447 · Alpha Therapeutic Corp.
510(k) numberK820447
Submission
- Device name
- Alpha Plasma Transfer Set
- Applicant
- Alpha Therapeutic Corp.
Mchenry, IL, US - Received
- February 18, 1982
- Decision date
- April 14, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K001043 | Kawasumi Laboratory Blood Drawing KitKSB · Traditional | Kawasumi Laboratories America, Inc. | 05/19/2000SE |
| 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 |
|---|---|---|
| K970225 | Alpha Micron 20/40 Microaggregate FilterCAK · Traditional | 02/14/1997SE |
| K955515 | Alpha Micron 20 Microaggregate FilterCAK · Traditional | 02/12/1996SE |
| K854920 | Therapy CassettsMCU · Traditional | 05/19/1986SN |
| K854441 | Stuart Gilman's Weight Loss PlanLDQ · Traditional | 02/10/1986SE |
| K833294 | Alpha Y-Recipient SetBRZ · Traditional | 12/27/1983SE |
| K810897 | Alpha Plastic Plasma BottleKSR · Traditional | 09/23/1981SE |
| K810761 | Alpha MICRON-40 FilterCAK · Traditional | 06/30/1981SE |
Questions and answers
When was Alpha Plasma Transfer Set cleared by the FDA?
Alpha Plasma Transfer Set (K820447) received a 510(k) decision of Substantially Equivalent on April 14, 1982, 55 days after the submission was received.
What is the product code of K820447?
The FDA product code is KSB – Set, Transfer (Blood/Plasma), a Class II (moderate risk) device regulated under 21 CFR 864.9875.