Gastrin 34 Hormone by Radioummunoassay
FDA 510(k) K842079 · Immuno Nuclear Corp.
510(k) numberK842079
Submission
- Device name
- Gastrin 34 Hormone by Radioummunoassay
- Applicant
- Immuno Nuclear Corp.
Mchenry, IL, US - Received
- May 23, 1984
- Decision date
- June 26, 1984
- 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 |
| 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 |
| K812727 | Gastrin 1-17 by Radioimmunoassay KitCGC · Traditional | Immuno Nuclear Corp. | 11/05/1981SE |
| 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 |
More from Inter Science Institute
| 510(k) | Device | Decision |
|---|---|---|
| K863743 | Biotech's Ige Immuno Response Test Isotope UnitDHB · Traditional | 12/15/1986SE |
| K863973 | Elm Allergen DiscDHB · Traditional | 12/01/1986SE |
| K863844 | Immuno Biotech's Lamb's Quarters Allergen DiscDHB · Traditional | 10/29/1986SE |
| K863123 | Immuno Biotech Mugwart Allergen DiscDHB · Traditional | 10/01/1986SE |
| K863098 | Meadow Fescue Allergen DiscDHB · Traditional | 09/15/1986SE |
| K862266 | Maple Allergen DiscDHB · Traditional | 08/19/1986SE |
| K862939 | Orchard Grass Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862938 | June Grass Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862265 | Cottonwood Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862176 | Russian Thistle Allergen DiscDHB · Traditional | 08/15/1986SE |
Questions and answers
When was Gastrin 34 Hormone by Radioummunoassay cleared by the FDA?
Gastrin 34 Hormone by Radioummunoassay (K842079) received a 510(k) decision of Substantially Equivalent on June 26, 1984, 34 days after the submission was received.
What is the product code of K842079?
The FDA product code is CGC – Radioimmunoassay, Gastrin, a Class I (low risk) device regulated under 21 CFR 862.1325.