510(k) K121944
- Device
- LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
- Applicant
- DIASORIN, INC.
- 510(k) number
- K121944
- Product code
- CIB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-01-01
- Date received
- 2012-07-03
- Regulation
- 862.1085
- Classification name
- Radioimmunoassay, Angiotensin I And Renin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Mari Meyer
- Address
- 1951 Northwestern Ave. Stillwater MN US 55082 55082
FDA Registration Numbers#
- 8021924
- 3007118747
- 9610240
Source Documents#
Other 510(k) Records For Product Code CIB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123763 | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS | Immunodiagnostic Systems , Ltd. | 2013-12-24 |
| K062120 | CISBIO RENIN RIA TEST | Cis Bio International | 2007-03-30 |
| K061758 | ACTIVE RENIN IRMA | Diagnostic Systems Laboratories, Inc. | 2006-07-28 |
| K011128 | NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) | Nichols Institute Diagnostics | 2001-09-06 |
| K981607 | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 | Diagnostic Systems Laboratories, Inc. | 1998-05-27 |
| K954299 | BUHLMANN ANGIOSTENSIN II RIA | Buhlmann Laboratories AG | 1995-10-19 |
| K940004 | AI-PHOTODIAGNOSTIC | Pharmarceutical Discovery Corp. | 1995-08-04 |
| K925998 | ACTIVE RENIN IMMUNORADIOMETRIC ASSAY | Nichols Institute Diagnostics | 1993-01-06 |
| K850054 | RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI | E.I. Dupont DE Nemours & Co., Inc. | 1985-03-29 |
| K842966 | RENIN RADIOIMMUNOASSAY TEST KIT | Serono Diagnostics, Inc. | 1984-10-11 |
| K833777 | ANGIOTENSIN CONVERTING ENZYME | Immuno-Diagnostic Laboratories | 1984-01-30 |
| K831694 | RENAK | Hoffmann-La Roche, Inc. | 1983-07-19 |
| K820616 | ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY | E. R. Squibb & Sons, Inc. | 1982-03-26 |
| K800774 | RENCTK | Sorin Biomedica, Fiat, USA, Inc. | 1980-04-21 |
| K761267 | ANGIOTENSIN I IMMUTOPE KIT | Squibb & Sons, Inc. | 1976-12-30 |
Legacy Summary#
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FDA Review#
Decision Summary