Blood Gas & Flame Photometer Instru-
FDA 510(k) K831075 · United Diagnostics, Inc.
510(k) numberK831075
Submission
- Device name
- Blood Gas & Flame Photometer Instru-
- Applicant
- United Diagnostics, Inc.
Mchenry, IL, US - Received
- April 4, 1983
- Decision date
- June 22, 1983
- 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 |
| 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 |
|---|---|---|
| K884977 | Gas Trak PlusJJY · Traditional | 01/27/1989SE |
| K862278 | Gas-TrakJJY · Traditional | 08/04/1986SE |
| K844018 | Gas Trak Brand Co-Oximeter Controls 1,2 & 3JJY · Traditional | 11/27/1984SE |
| K843986 | Stat-Trak Plus Liquid Chemistry Controls 1,2 & 3JJY · Traditional | 11/27/1984SE |
| K831389 | Stat-Trak Liquid Electrolyte ControlJJR · Traditional | 08/10/1983SE |
| K831814 | Calibration Standard-HemoglobinKRZ · Traditional | 07/28/1983SE |
| K831813 | Co-Oximeter ControlKHG · Traditional | 07/28/1983SE |
| K820705 | Gas-Trak 2 Synthetic Blood Gas ControlJJS · Traditional | 04/01/1982SE |
| K813517 | Blood Gas Analysis, Standards ControlsCHL · Traditional | 12/31/1981SE |
| K810618 | Ampuled Flame Photometer StandardsJIS · Traditional | 03/31/1981SE |
Questions and answers
When was Blood Gas & Flame Photometer Instru- cleared by the FDA?
Blood Gas & Flame Photometer Instru- (K831075) received a 510(k) decision of Substantially Equivalent on June 22, 1983, 79 days after the submission was received.
What is the product code of K831075?
The FDA product code is CGC – Radioimmunoassay, Gastrin, a Class I (low risk) device regulated under 21 CFR 862.1325.