Biospal 2400S
FDA 510(k) K834579 · Hospal Medical Corp.
510(k) numberK834579
Submission
- Device name
- Biospal 2400S
- Applicant
- Hospal Medical Corp.
Mchenry, IL, US - Received
- December 29, 1983
- Decision date
- February 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KDT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873593 | Biosure Specimen Collection ContainerKDT · Traditional | Biosure, Inc. | 11/25/1987SE |
| K862665 | Novacyte-UKDT · Traditional | Xsirius Medical, Inc. | 09/04/1986SE |
| K834412 | Preserv Pva Fixative 15ML-FORMALIN PKKDT · Traditional | Preventive Diagnostics Corp. | 01/13/1984SE |
| K833660 | Preserv Pva Fixative -Malin PackKDT · Traditional | Preventive Diagnostics Corp. | 11/28/1983SE |
| K823773 | Provial II #006-010-0201KDT · Traditional | Dynatech Corp. | 01/21/1983SE |
| K822870 | Stool-Collection/Preservation KitKDT · Traditional | American Scientific Products | 11/01/1982SE |
| K821621 | PregnopostKDT · Traditional | M.M. Wolfred, Ph.D. | 07/21/1982SE |
| K820246 | Prefilled Specimen ContainerKDT · Traditional | Sage Products, Inc. | 02/18/1982SE |
| K811793 | Fix-Right 90ML & 180 ML Prefilled ContKDT · Traditional | Richard-Allan Medical Ind., Inc. | 07/31/1981SE |
| K800946 | Urinary Catheter Sampling KitKDT · Traditional | Sage Products, Inc. | 06/20/1980SE |
More from Sage Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K893742 | Filtral TM 20 Hemodialyzer/FilterKDI · Traditional | 07/24/1989SE |
| K884365 | Multiflow(Tm) 60 KitKDI · Traditional | 12/08/1988SE |
| K884326 | Filtral TM 8 HemodialyzerKDI · Traditional | 12/05/1988SE |
| K883307 | Cardioflow 100 Hemoconcentrator/Preparation KitKDI · Traditional | 10/12/1988SE |
| K872767 | Filtral 10, Filtral 12, Filtral 16 HemodialyzerKDI · Traditional | 12/29/1987SE |
| K871218 | Monitral S GS Hemodialysis Single Patient UnitFKP · Traditional | 04/30/1987SE |
| K863961 | Hospal Biospal 1800SKDI · Traditional | 12/17/1986SE |
| K863592 | Disscap 80E, 110E, 140E, 160EFJI · Traditional | 09/25/1986SE |
| K861156 | Hospal Dialysate for CavhdKPO · Traditional | 09/23/1986SE |
| K861230 | Monitral SFKP · Traditional | 04/25/1986SE |
Questions and answers
When was Biospal 2400S cleared by the FDA?
Biospal 2400S (K834579) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 37 days after the submission was received.
What is the product code of K834579?
The FDA product code is KDT – Container, Specimen Mailer And Storage, Sterile, a Class I (low risk) device regulated under 21 CFR 864.3250.