Eldoncard
FDA 510(k) K790282 · Nordisk Infuser System
510(k) numberK790282
Submission
- Device name
- Eldoncard
- Applicant
- Nordisk Infuser System
Walker, MI, US - Received
- February 13, 1979
- Decision date
- May 4, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSZ – System, Test, Automated Blood Grouping And Antibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9175
- Specialty
- Hematology
Other 510(k)s with product code KSZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K810899 | Technicon Autogrouper 16-C SystemKSZ · Traditional | Technicon Instruments Corp. | 05/05/1981SE |
| K771098 | Blood Grouping Sys., BG-9KSZ · Traditional | Technicon Instruments Corp. | 08/04/1977SE |
| K770185 | RH Control DiluentKSZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/14/1977SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K860492 | Nordisk Infuser System with Pre-Filled CartridgeFRN · Traditional | 02/19/1986SE |
Questions and answers
When was Eldoncard cleared by the FDA?
Eldoncard (K790282) received a 510(k) decision of Substantially Equivalent on May 4, 1979, 80 days after the submission was received.
What is the product code of K790282?
The FDA product code is KSZ – System, Test, Automated Blood Grouping And Antibody, a Class II (moderate risk) device regulated under 21 CFR 864.9175.