Leeco Dig-Quant Diag. Test Kit
FDA 510(k) K830785 · Leeco Diagnostics, Inc.
510(k) numberK830785
Submission
- Device name
- Leeco Dig-Quant Diag. Test Kit
- Applicant
- Leeco Diagnostics, Inc.
Mchenry, IL, US - Received
- March 11, 1983
- Decision date
- April 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Leeco Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K895765 | Leeco Preview(R) Ebv (Eia)KTN · Traditional | 10/31/1989SE |
| K894122 | Leeco Vis-Disk Strep-A (Eia)GTZ · Traditional | 08/15/1989SE |
| K891096 | Vis-Disk HCG (Eia) JPL-041MDHA · Traditional | 06/16/1989SE |
| K891095 | Vis-Disk HCG (Eia) Lyophilized JPL-044MDHA · Traditional | 06/16/1989SE |
| K883269 | Prl-QuantCFT · Traditional | 09/13/1988SE |
| K880577 | CONCEP-7-BHCGJHI · Traditional | 03/15/1988SE |
| K880069 | Leeco Pregnastick (Eia) Catalog #003LCX · Traditional | 02/11/1988SE |
| K870259 | Vis-Cube HCG (Eia) Lyophilized JPL-044JHI · Traditional | 03/10/1987SE |
| K864170 | Leeco Vis-Cube Strep a (Eia)GTZ · Traditional | 02/03/1987SE |
| K863999 | Vis-Cube Pregnancy Home Test,Cat. # JPL-042LCX · Traditional | 01/09/1987SE |
Questions and answers
When was Leeco Dig-Quant Diag. Test Kit cleared by the FDA?
Leeco Dig-Quant Diag. Test Kit (K830785) received a 510(k) decision of Substantially Equivalent on April 8, 1983, 28 days after the submission was received.