Atlas FDA

MICROSCAN MICROSTREP PLUS, MODEL B1027-201

FDA 510(k) clearance K091949 · decided 2010-01-26

Clearance details

K-number
K091949
Device name
MICROSCAN MICROSTREP PLUS, MODEL B1027-201
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2009-07-01
Decision date
2010-01-26
Days to decision
209 days
Clearance type
Special
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

RecordFirmDate
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Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MI recall (Z-1272-2013)Siemens Healthcare Diagnostics, Inc.2013-05-08

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