Atlas FDA

MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)

FDA 510(k) clearance K020249 · decided 2002-02-06

Clearance details

K-number
K020249
Device name
MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)
Applicant
Dade Behring, Inc.
Decision
Substantially Equivalent
Date received
2002-01-24
Decision date
2002-02-06
Days to decision
13 days
Clearance type
Traditional
Product code
LON
Device class
2
Regulation number
866.1645
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
West Sacramento, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan Synergies plus Pa recall (Z-2119-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan Synergies plus Panels & recall (Z-2120-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan Synergies pl recall (Z-2121-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan Synergies plus Pa recall (Z-2122-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan Synergies plus Pa recall (Z-2123-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan Synergie recall (Z-2124-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan Sy recall (Z-2125-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroSc recall (Z-2126-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan Synergies plus recall (Z-2127-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan Synergies plu recall (Z-2128-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan Synergies plu recall (Z-2129-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11

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