510(k) K103557
- Device
- DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
- Applicant
- DIAZYME LABORATORIES
- 510(k) number
- K103557
- Product code
- DCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-04-27
- Date received
- 2010-12-02
- Regulation
- 866.5270
- Classification name
- C-reactive Protein, Antigen, Antiserum, And Control
- Medical specialty
- Immunology
- 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
- 8020316
- 3006198300
- 3002800697
- 3005360469
- 2030861
- 9680746
- 2050012
- 2245285
- 3005333358
- 2432235
- 2025099
- 3022178699
- 1319809
- 3012963943
- 3026565854
- 2250051
- 1832216
- 1319808
- 3002809144
- 1181055
- 1000403749
- 9613069
- 1827821
- 3011989923
- 3014607865
- 3019906
- 3004493545
- 3002642396
- 3005984081
- 2050010
- 2032900
- 3017505309
- 3012471076
- 9610102
- 2085064
- 3003871639
- 9681753
- 9610126
- 2029372
- 1220972
- 1319681
- 3000308930
- 2431980
- 3000148879
- 9614373
Source Documents#
Other 510(k) Records For Product Code DCK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242170 | K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC | 2025-04-18 |
| K201256 | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge | Procise Diagnostics | 2022-11-04 |
| K192028 | Yumizen C1200 CRP | HORIBA ABX SAS | 2020-06-25 |
| K192118 | CRP Vario | SENTINEL CH. SpA | 2019-11-08 |
| K191993 | Yumizen C1200 CRP | HORIBA ABX SAS | 2019-10-03 |
| K160712 | VITROS Chemistry Products hsCRP Reagent | Ortho Clinical Diagnostics | 2017-07-14 |
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument | Orion Diagnostica, OY | 2016-03-10 |
| K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 | Ortho Clinical Diagnostics | 2015-09-24 |
| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit | Qualigen, Inc. | 2015-01-07 |
| K121558 | DIAZYME HSCRP POC TEST KIT | Diazyme Laboratories | 2012-09-21 |
| K061138 | ABX PENTRA 400 : CRP | Horiba Abx | 2006-09-29 |
| K060139 | CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 | Diagnostic Chemicals , Ltd. | 2006-04-28 |
| K052591 | NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT | Clinical Data, Inc. | 2006-02-09 |
| K050836 | CRP DIAGNOSTIC ASSAY | Sentinel Ch. Srl | 2005-08-08 |
| K041155 | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY | Stanbio Laboratory | 2004-10-14 |
Legacy Summary#
summary
FDA Review#
Decision Summary