Infectious Tissue Kit
FDA 510(k) K864824 · American Scientific Products
510(k) numberK864824
Submission
- Device name
- Infectious Tissue Kit
- Applicant
- American Scientific Products
Waukegan, IL, US - Received
- December 9, 1986
- Decision date
- December 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from American Scientific Products
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K822799 | Streptacoccus Co-Agglutination KitGTP · Traditional | 12/19/1982SE |
Questions and answers
When was Infectious Tissue Kit cleared by the FDA?
Infectious Tissue Kit (K864824) received a 510(k) decision of Substantially Equivalent on December 24, 1986, 15 days after the submission was received.