510(k) K062924
- Device
- STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K062924
- Product code
- NQD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-12-26
- Date received
- 2006-09-28
- Regulation
- 866.5270
- Classification name
- Cardiac 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
- PAMELA A JURGA
- Address
- P.O. Box 6101 Bldg. 500;M.S.514 Newark DE US 19714 19714
FDA Registration Numbers#
- 3006198300
- 3003795116
- 9610806
- 9680746
- 2050012
- 3005333358
- 2432235
- 9610529
- 3012963943
- 2250051
- 1319808
- 3002809144
- 2517506
- 3011989923
- 3002637618
- 3004493545
- 3002642396
- 2050010
- 9681753
- 9610126
- 1319681
- 3021841051
- 3000308930
- 3002806944
Source Documents#
Other 510(k) Records For Product Code NQD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260026 | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | 2026-04-02 |
| K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics, Inc. | 2024-01-18 |
| K212559 | CardioPhase® hsCRP | Siemens Healthcare Diagnostics Products GmbH | 2022-12-16 |
| K173833 | CRP Vario | SENTINEL CH. SpA | 2018-09-27 |
| K081294 | ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | 2008-07-29 |
| K071002 | IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT | Beckman Coulter, Inc. | 2007-06-21 |
| K070626 | SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT | Beckman Coulter, Inc. | 2007-05-04 |
| K071017 | IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) | Siemens Medical Solutions Diagnostics | 2007-05-02 |
| K063057 | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP | Diagnostic Products Corporation | 2006-12-22 |
| K061802 | DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH | Dade Behring, Inc. | 2006-09-11 |
| K060369 | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK | Dade Behring, Inc. | 2006-05-04 |
| K053603 | C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS | Roche Diagnostics Corp. | 2006-02-09 |
| K053109 | DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2005-12-23 |
| K051564 | OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH | Olympus America, Inc. | 2005-08-22 |
| K042485 | TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) | Roche Diagnostics Corp. | 2004-10-29 |
Legacy Summary#
summary
FDA Review#
Decision Summary