Pregnopost
FDA 510(k) K821621 · M.M. Wolfred, Ph.D.
510(k) numberK821621
Submission
- Device name
- Pregnopost
- Applicant
- M.M. Wolfred, Ph.D.
Mchenry, IL, US - Received
- June 2, 1982
- Decision date
- July 21, 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 |
| 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 |
Questions and answers
When was Pregnopost cleared by the FDA?
Pregnopost (K821621) received a 510(k) decision of Substantially Equivalent on July 21, 1982, 49 days after the submission was received.
What is the product code of K821621?
The FDA product code is KDT – Container, Specimen Mailer And Storage, Sterile, a Class I (low risk) device regulated under 21 CFR 864.3250.