STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
FDA 510(k) clearance K984065 · decided 1998-12-14
Clearance details
- K-number
- K984065
- Device name
- STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-16
- Decision date
- 1998-12-14
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DDR
- Device class
- 2
- Regulation number
- 866.5680
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stratus CS STAT Fluorometric Analyzer MYO TestPak (CMYO) in vitro diagnostic. recall (Z-0878-06) | Dade Behring , Inc. | 2006-05-19 |
| Stratus CS STAT Fluorometric Analyzer MYO DilPak (CMYO-D) in vitro diagnostic. recall (Z-0884-06) | Dade Behring , Inc. | 2006-05-19 |
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 |