Alpha Plastic Plasma Bottle
FDA 510(k) K810897 · Alpha Therapeutic Corp.
510(k) numberK810897
Submission
- Device name
- Alpha Plastic Plasma Bottle
- Applicant
- Alpha Therapeutic Corp.
Mchenry, IL, US - Received
- April 3, 1981
- Decision date
- September 23, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSR – Container, Empty, For Collection & Processing Of Blood & Blood Components
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9100
- Specialty
- Hematology
Other 510(k)s with product code KSR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032827 | Kendall Lifetrace Umbilical Blood Collection Kit, Code 56501KSR · Traditional | Tyco Healthcare | 12/08/2003SE |
| K020753 | Deroyal Surgical, UmbilicupKSR · Traditional | Deroyal | 06/13/2002SE |
| K810500 | Blood Freezing BagKSR · Traditional | Delmed, Inc. | 09/23/1981SE |
| K811523 | Plasma FlexKSR · Traditional | Terumo America, Inc. | 09/09/1981SE |
| K811449 | Haemonetics 1000ML Component BagKSR · Traditional | Haemonetics Corp. | 07/01/1981SE |
| K810711 | Haemonetics 600 Ml. Component BagKSR · Traditional | Haemonetics Corp. | 05/08/1981SE |
| K810313 | Haemonetics 1400 ML Therapeutic BagKSR · Traditional | Haemonetics Corp. | 03/31/1981SE |
| K801219 | PlasmapoolerKSR · Traditional | North American Biologicals, Inc. | 10/31/1980SE |
| K801082 | Gambro Hemofreeze-BagKSR · Traditional | Gambro, Inc. | 10/31/1980SE |
| K792395 | Pharmaflex Cryogenic BagKSR · Traditional | Pharmachem Corp. | 02/26/1980SE |
More from Pharmachem Corp.
| 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 |
| K820447 | Alpha Plasma Transfer SetKSB · Traditional | 04/14/1982SE |
| K810761 | Alpha MICRON-40 FilterCAK · Traditional | 06/30/1981SE |
Questions and answers
When was Alpha Plastic Plasma Bottle cleared by the FDA?
Alpha Plastic Plasma Bottle (K810897) received a 510(k) decision of Substantially Equivalent on September 23, 1981, 173 days after the submission was received.
What is the product code of K810897?
The FDA product code is KSR – Container, Empty, For Collection & Processing Of Blood & Blood Components, a Class II (moderate risk) device regulated under 21 CFR 864.9100.