OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH
FDA 510(k) clearance K051564 · decided 2005-08-22
Clearance details
- K-number
- K051564
- Device name
- OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-14
- Decision date
- 2005-08-22
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- NQD
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Irving, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Tina-quant Cardiac high sensitivity CRP III (K260026) | Roche Diagnostics | 2026-04-02 |
| Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) (K233242) | Siemens Healthcare Diagnostics, Inc. | 2024-01-18 |
| CardioPhase® hsCRP (K212559) | Siemens Healthcare Diagnostics Products GmbH | 2022-12-16 |
| CRP Vario (K173833) | SENTINEL CH. SpA | 2018-09-27 |
| ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS (K081294) | Siemens Healthcare Diagnostics, Inc. | 2008-07-29 |
| IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT (K071002) | Beckman Coulter, Inc. | 2007-06-21 |
| SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT (K070626) | Beckman Coulter, Inc. | 2007-05-04 |
| IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) (K071017) | Siemens Medical Solutions Diagnostics | 2007-05-02 |
| STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK (K062924) | Dade Behring, Inc. | 2006-12-26 |
| IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP (K063057) | Diagnostic Products Corporation | 2006-12-22 |
| DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH (K061802) | Dade Behring, Inc. | 2006-09-11 |
| STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK (K060369) | Dade Behring, Inc. | 2006-05-04 |
Recalls involving this device
No recalls on record reference this clearance.