Atlas FDA

STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK

FDA 510(k) clearance K984067 · decided 1999-01-13

Clearance details

K-number
K984067
Device name
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
Applicant
Dade Behring, Inc.
Decision
Substantially Equivalent
Date received
1998-11-16
Decision date
1999-01-13
Days to decision
58 days
Clearance type
Traditional
Product code
JHX
Device class
2
Regulation number
862.1215
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

RecordFirmDate
Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09 Intended use: Stratus( recall (Z-0343-2011)Siemens Healthcare Diagnostics, Inc.2010-11-10
Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic. recall (Z-0875-06)Dade Behring , Inc.2006-05-19

PMA approvals by this applicant

RecordFirmDate
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