Prefilled Specimen Container
FDA 510(k) K820246 · Sage Products, Inc.
510(k) numberK820246
Submission
- Device name
- Prefilled Specimen Container
- Applicant
- Sage Products, Inc.
Mchenry, IL, US - Received
- January 29, 1982
- Decision date
- February 18, 1982
- 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 |
| K834579 | Biospal 2400SKDT · Traditional | Hospal Medical Corp. | 02/04/1984SE |
| 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 |
| 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 |
|---|---|---|
| K972705 | Resheather Device-Metal or Plastic, Resheater/ Needle Holder Device-PlasticFMI · Traditional | 04/30/1998SE |
| K980490 | Sage Products Inc, Sharps Disposal Containers with Screw Top CapsMMK · Traditional | 02/24/1998SE |
| K973911 | 2 Gallon Alternate Care Sharps ContainerFMI · Traditional | 10/29/1997SE |
| K972279 | Sharps ShuttleFMI · Traditional | 08/29/1997SE |
| K970135 | Nitrile GlovesLZC · Traditional | 08/25/1997SE |
| K972302 | Pocket Count or SafetcountLWH · Traditional | 07/25/1997SE |
| K964168 | Procedure Specific KitsFXX · Traditional | 03/03/1997SE |
| K963986 | STP System Pva with ZincLIO · Traditional | 11/08/1996SE |
| K964026 | STP System - SafLIO · Traditional | 11/07/1996SE |
| K964027 | STP System-Pva with MercuryLIO · Traditional | 11/01/1996SE |
Questions and answers
When was Prefilled Specimen Container cleared by the FDA?
Prefilled Specimen Container (K820246) received a 510(k) decision of Substantially Equivalent on February 18, 1982, 20 days after the submission was received.
What is the product code of K820246?
The FDA product code is KDT – Container, Specimen Mailer And Storage, Sterile, a Class I (low risk) device regulated under 21 CFR 864.3250.