Thyro-Count Thyroid Uptake System 90IZD Probe
FDA 510(k) K827748 · Kemble Instruments, Inc.
510(k) numberK827748
Submission
- Device name
- Thyro-Count Thyroid Uptake System 90IZD Probe
- Applicant
- Kemble Instruments, Inc.
Raleigh, NC, US - Received
- July 20, 1982
- Decision date
- August 16, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Kemble Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K842894 | Kemble 405JQW · Traditional | 08/27/1984SE |
| K832760 | Ria SoftwareJQP · Traditional | 10/14/1983SE |
| K832734 | Kemtek 400 Ria Gamma CounterJJJ · Traditional | 10/14/1983SE |
| K832736 | Kemtek 104 Ria Gamma CounterJJJ · Traditional | 09/29/1983SE |
| K832735 | Kemtek 103 Ria Gamma CounterJJJ · Traditional | 09/29/1983SE |
| K830751 | Kemtek 102JJJ · Traditional | 04/06/1983SE |
| K822293 | Immu-Count 404JJJ · Traditional | 08/24/1982SE |
| K820137 | Immu-CountJJJ · Traditional | 02/05/1982SE |
Questions and answers
When was Thyro-Count Thyroid Uptake System 90IZD Probe cleared by the FDA?
Thyro-Count Thyroid Uptake System 90IZD Probe (K827748) received a 510(k) decision of Substantially Equivalent on August 16, 1982, 27 days after the submission was received.