510(k) K123763
- Device
- IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
- Applicant
- IMMUNODIAGNOSTIC SYSTEMS LTD.
- 510(k) number
- K123763
- Product code
- CIB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-12-24
- Date received
- 2012-12-07
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICK FENTON
- Address
- 10 Didcot Way, Bolden Business Park Boldon, Tyne & Wear GB NE35 9PD NE35 9PD
FDA Registration Numbers#
- 8021924
- 3007118747
- 9610240
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CIB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121944 | LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT | DiaSorin, Inc. | 2013-01-01 |
| 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