Gastrin 1-17 by Radioimmunoassay Kit
FDA 510(k) K812727 · Immuno Nuclear Corp.
510(k) numberK812727
Submission
- Device name
- Gastrin 1-17 by Radioimmunoassay Kit
- Applicant
- Immuno Nuclear Corp.
Mchenry, IL, US - Received
- September 28, 1981
- Decision date
- November 5, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGC – Radioimmunoassay, Gastrin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1325
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961276 | Gastrin Eia Model 06B-555017CGC · Traditional | Biosyn , Ltd. | 05/30/1996SE |
| K842079 | Gastrin 34 Hormone by RadioummunoassayCGC · Traditional | Immuno Nuclear Corp. | 06/26/1984SE |
| K841963 | Gastrin RiaCGC · Traditional | Syncor Intl. Corp. | 06/25/1984SE |
| K833489 | DPC Gastrin KitCGC · Traditional | Diagnostic Products Corp. | 01/30/1984SE |
| K831075 | Blood Gas & Flame Photometer Instru-CGC · Traditional | United Diagnostics, Inc. | 06/22/1983SE |
| K821175 | Gastrin Radioimmunoassay Kit (125-I)CGC · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/14/1982SE |
| K812004 | Gastrin Ria Diagnostic KitCGC · Traditional | Abbott Laboratories | 07/28/1981SE |
| K810722 | Gastrin Radioimmunoassay TestCGC · Traditional | Clinical Assays, Inc. | 05/27/1981SE |
| K771953 | Gastrin Ria ModuleCGC · Traditional | Inter Science Institute | 01/20/1978SE |
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Questions and answers
When was Gastrin 1-17 by Radioimmunoassay Kit cleared by the FDA?
Gastrin 1-17 by Radioimmunoassay Kit (K812727) received a 510(k) decision of Substantially Equivalent on November 5, 1981, 38 days after the submission was received.
What is the product code of K812727?
The FDA product code is CGC – Radioimmunoassay, Gastrin, a Class I (low risk) device regulated under 21 CFR 862.1325.