Atlas FDA

MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN

FDA 510(k) clearance K062773 · decided 2006-10-13

Clearance details

K-number
K062773
Device name
MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
Applicant
Dade Behring, Inc.
Decision
Substantially Equivalent
Date received
2006-09-18
Decision date
2006-10-13
Days to decision
25 days
Clearance type
Traditional
Product code
LTT
Device class
2
Regulation number
866.1640
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

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MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panel recall (Z-0109-2016)Beckman Coulter Inc.2015-10-07

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