Diagnostic Kit, FERRITAB-FE-59
FDA 510(k) K782159 · Leeco Diagnostics, Inc.
510(k) numberK782159
Submission
- Device name
- Diagnostic Kit, FERRITAB-FE-59
- Applicant
- Leeco Diagnostics, Inc.
Mchenry, IL, US - Received
- December 22, 1978
- Decision date
- February 1, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJA – Radio-Labeled Iron Method, Iron (Non-Heme)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1410
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K820253 | Simul-Fer Serum Iron Test KitJJA · Traditional | Diagnostic Reagents, Inc. | 05/12/1982SE |
| K781769 | Iron 59 KitJJA · Traditional | Ria Products, Inc. | 12/04/1978SE |
| K760045 | Kit, Radioassay, Serum IronJJA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/20/1976SE |
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| 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 Diagnostic Kit, FERRITAB-FE-59 cleared by the FDA?
Diagnostic Kit, FERRITAB-FE-59 (K782159) received a 510(k) decision of Substantially Equivalent on February 1, 1979, 41 days after the submission was received.
What is the product code of K782159?
The FDA product code is JJA – Radio-Labeled Iron Method, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.