Gastrin Radioimmunoassay Test Kit
FDA 510(k) K842965 · Serono Diagnostics, Inc.
510(k) numberK842965
Submission
- Device name
- Gastrin Radioimmunoassay Test Kit
- Applicant
- Serono Diagnostics, Inc.
Bramtree, MA, US - Received
- July 27, 1984
- Decision date
- October 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Serono Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953598 | Series 9100 Plus Automated Differential Hematology AnalyzersGKZ · Traditional | 03/11/1996SE |
| K942051 | SR1 Dhea-S Enzyme ImmunoassayJKC · Traditional | 07/13/1994SE |
| K883085 | T3 Uptake Serozyme Enzyme Immuno Kt/Mag Solid PhasKHQ · Traditional | 09/09/1988SE |
| K882340 | LH Serozyme Immunoenzymetric Assay Kit,Mag Sol PhaCEP · Traditional | 08/08/1988SE |
| K880388 | T3 Serozyme Enzymeimmunoassay Kit, Mag Solid PhaseCDP · Traditional | 03/03/1988SE |
| K874866 | T4 Serozyme Enzymeimmunoassay Kit/Mag. Solid PhaseKLI · Traditional | 02/11/1988SE |
| K873431 | Progesterone Maia Radioimmuno Assay Kit Mag SLD PHJLS · Traditional | 10/20/1987SE |
| K873186 | LH Maiaclone Immunoradio. Assay Kit, Mag Solid PhaCEP · Traditional | 09/29/1987SE |
| K873400 | Prolactin Maiaclone Immunoradio. Kit, Mag Sol PhaCFT · Traditional | 09/25/1987SE |
| K872862 | PRL Serozyme Immunoenz. Assay Kit, Mag. Solid PhasCFT · Traditional | 09/18/1987SE |
Questions and answers
When was Gastrin Radioimmunoassay Test Kit cleared by the FDA?
Gastrin Radioimmunoassay Test Kit (K842965) received a 510(k) decision of Substantially Equivalent on October 11, 1984, 76 days after the submission was received.