Stool-Collection/Preservation Kit
FDA 510(k) K822870 · American Scientific Products
510(k) numberK822870
Submission
- Device name
- Stool-Collection/Preservation Kit
- Applicant
- American Scientific Products
Mchenry, IL, US - Received
- September 27, 1982
- Decision date
- November 1, 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 |
| 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 |
|---|---|---|
| K864824 | Infectious Tissue Kit · Traditional | 12/24/1986SE |
| K844042 | Blood Dilution VialGKL · Traditional | 10/23/1984SE |
| K831634 | Glucose Reagent B6360-11CGA · Traditional | 07/19/1983SE |
| K831626 | Urea Nitrogen-Bun-Reagents B6370-11ACDQ · Traditional | 07/07/1983SE |
| K831625 | Urea Nitrogen-Bun-Reagents B6360-12CDQ · Traditional | 07/07/1983SE |
| K831628 | Creatinine Reagents B6370-13CGX · Traditional | 07/06/1983SE |
| K831627 | Creatinine Reagents B6360-10CGX · Traditional | 07/06/1983SE |
| K831624 | Glucose Reagent KITS-B6370-10ACGA · Traditional | 07/06/1983SE |
| K831571 | RotorJJG · Traditional | 06/30/1983SE |
| K831569 | Reagent CupsJJG · Traditional | 06/30/1983SE |
Questions and answers
When was Stool-Collection/Preservation Kit cleared by the FDA?
Stool-Collection/Preservation Kit (K822870) received a 510(k) decision of Substantially Equivalent on November 1, 1982, 35 days after the submission was received.
What is the product code of K822870?
The FDA product code is KDT – Container, Specimen Mailer And Storage, Sterile, a Class I (low risk) device regulated under 21 CFR 864.3250.