STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK
FDA 510(k) clearance K060548 · decided 2006-04-06
Clearance details
- K-number
- K060548
- Device name
- STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-03-01
- Decision date
- 2006-04-06
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- DHA
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for cal recall (Z-0615-2016) | Siemens Healthcare Diagnostics Inc | 2016-01-07 |
| Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibra recall (Z-0617-2016) | Siemens Healthcare Diagnostics Inc | 2016-01-07 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003) | Dade Behring, Inc. | 2002-07-24 |
| COBAS INTEGRA CYCLOSPORINE (P920031/S002) | Dade Behring, Inc. | 2002-02-26 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001) | Dade Behring, Inc. | 2000-08-11 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031) | Dade Behring, Inc. | 1996-10-02 |