Assay System, Gammaflo, Automated
FDA 510(k) K781659 · E. R. Squibb & Sons, Inc.
510(k) numberK781659
Submission
- Device name
- Assay System, Gammaflo, Automated
- Applicant
- E. R. Squibb & Sons, Inc.
New York, NY, US - Received
- September 28, 1978
- Decision date
- October 24, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from E. R. Squibb & Sons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K821494 | Ria Stat 16JJJ · Traditional | 06/03/1982SE |
| K820616 | Angiotensis I-Squibb RadioimmunoassayCIB · Traditional | 03/26/1982SE |
| K820341 | Cortisol-Squibb Radioimmunoassay KitCGR · Traditional | 03/04/1982SE |
| K820340 | T3 Uptake-Squibb Diagnostic KitKHQ · Traditional | 03/04/1982SE |
| K811240 | Sur-Fit Loop Ostomy O.R. SetEXB · Traditional | 06/16/1981SE |
| K811239 | Sur-Fit Disposable Convex InsertEXB · Traditional | 06/09/1981SE |
| K811160 | Sur-Fit Irrigation SleeveEXD · Traditional | 06/02/1981SE |
| K811163 | Sur-Fit Disposable Fange CapEXB · Traditional | 05/21/1981SE |
| K810966 | Diagoxin Squibb Radioimmunoassay KitDNL · Traditional | 04/21/1981SE |
| K810211 | T3 Ria KitCDP · Traditional | 02/10/1981SE |
Questions and answers
When was Assay System, Gammaflo, Automated cleared by the FDA?
Assay System, Gammaflo, Automated (K781659) received a 510(k) decision of Substantially Equivalent on October 24, 1978, 26 days after the submission was received.