510(k) K111664
- Device
- DIAZYME CYSTATIN C POC TEST KIT
- Applicant
- DIAZYME LABORATORIES
- 510(k) number
- K111664
- Product code
- NDY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-03-30
- Date received
- 2011-06-14
- Regulation
- 862.1225
- Classification name
- Test, Cystatin C
- 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
- Abhijit Datta
- Address
- 12889 Gregg Ct. Poway CA US 92064 92064
FDA Registration Numbers#
- 2084025
- 3006198300
- 3003795116
- 3009189893
- 9610099
- 9610806
- 3005333358
- 2432235
- 9610529
- 3002809144
- 9612316
- 1000403749
- 3003423869
- 1827821
- 8031673
- 3013059683
- 3004493545
- 3006801241
- 2032900
- 3012471076
- 9681753
- 3005529799
- 9610126
- 9614373
Source Documents#
Other 510(k) Records For Product Code NDY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242585 | Cystatin C | SENTINEL CH. SpA | 2025-05-16 |
| K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | Siemens Healthcare Diagnostics, Inc. | 2018-05-25 |
| K171072 | N Latex Cystatin C; N Protein Standard UY | Siemens Healthcare Diagnostics Products GmbH | 2017-05-12 |
| K161817 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics Operations (Rdo) | 2016-07-27 |
| K141143 | COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET | Roche Diagnostics | 2014-07-17 |
| K093137 | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL | Kamiya Biomedical Co. | 2010-09-28 |
| K093960 | ST AIA-PACK CYSTATIN C, MODEL 025217 | Tosoh Bioscience, Inc. | 2010-09-14 |
| K093680 | DIAZYME CYSTATIN C ASSAY | Diazyme Laboratories | 2010-04-08 |
| K083906 | ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 | Siemens Healthcare Diagnostics | 2009-03-11 |
| K081875 | GENTIAN CYSTATIN C IMMUNOASSAY | Gentian AS | 2008-08-20 |
| K080811 | TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET | Roche Diagnostics Corp. | 2008-06-20 |
| K080384 | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER | The Binding Site, Ltd. | 2008-06-06 |
| K080662 | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | Genzyme Corporation | 2008-05-15 |
| K072270 | DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) | Diazyme Laboratories | 2008-02-01 |
| K072166 | CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER | The Binding Site | 2008-01-24 |
Legacy Summary#
summary
FDA Review#
Decision Summary