GASTRIN RADIOIMMUNOASSAY TEST
FDA 510(k) clearance K810722 · decided 1981-05-27
Clearance details
- K-number
- K810722
- Device name
- GASTRIN RADIOIMMUNOASSAY TEST
- Applicant
- Clinical Assays, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-03-17
- Decision date
- 1981-05-27
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- CGC
- Device class
- 1
- Regulation number
- 862.1325
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GASTRIN EIA MODEL 06B-555017 (K961276) | Biosyn , Ltd. | 1996-05-30 |
| GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY (K842079) | Immuno Nuclear Corp. | 1984-06-26 |
| GASTRIN RIA (K841963) | Syncor Intl. Corp. | 1984-06-25 |
| DPC GASTRIN KIT (K833489) | Diagnostic Products Corp. | 1984-01-30 |
| BLOOD GAS & FLAME PHOTOMETER INSTRU- (K831075) | United Diagnostics, Inc. | 1983-06-22 |
| GASTRIN RADIOIMMUNOASSAY KIT (125-I) (K821175) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-05-14 |
| GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT (K812727) | Immuno Nuclear Corp. | 1981-11-05 |
| GASTRIN RIA DIAGNOSTIC KIT (K812004) | Abbott Laboratories | 1981-07-28 |
| GASTRIN RIA MODULE (K771953) | Inter Science Institute | 1978-01-20 |
Recalls involving this device
No recalls on record reference this clearance.