510(k) K961276
- Device
- GASTRIN EIA MODEL 06B-555017
- Applicant
- BIOSYN LTD.
- 510(k) number
- K961276
- Product code
- CGC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-05-30
- Date received
- 1996-04-03
- Regulation
- 862.1325
- Classification name
- Radioimmunoassay, Gastrin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CONOR D MCGURK
- Address
- 10, Malone Rd. Belfast IE
FDA Registration Numbers#
- 9681721
- 3002806944
- 2419955
- 2032839
Source Documents#
Other 510(k) Records For Product Code CGC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842079 | GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY | Immuno Nuclear Corp. | 1984-06-26 |
| K841963 | GASTRIN RIA | Syncor Intl. Corp. | 1984-06-25 |
| K833489 | DPC GASTRIN KIT | Diagnostic Products Corp. | 1984-01-30 |
| K831075 | BLOOD GAS & FLAME PHOTOMETER INSTRU- | United Diagnostics, Inc. | 1983-06-22 |
| K821175 | GASTRIN RADIOIMMUNOASSAY KIT (125-I) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-05-14 |
| K812727 | GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT | Immuno Nuclear Corp. | 1981-11-05 |
| K812004 | GASTRIN RIA DIAGNOSTIC KIT | Abbott Laboratories | 1981-07-28 |
| K810722 | GASTRIN RADIOIMMUNOASSAY TEST | Clinical Assays, Inc. | 1981-05-27 |
| K771953 | GASTRIN RIA MODULE | Inter Science Institute | 1978-01-20 |
Legacy Summary#
summary
FDA Review#
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