Atlas FDA

MICROSCAN(R) MICROSTREP PLUS(R)

FDA 510(k) clearance K111677 · decided 2011-08-04

Clearance details

K-number
K111677
Device name
MICROSCAN(R) MICROSTREP PLUS(R)
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2011-06-15
Decision date
2011-08-04
Days to decision
50 days
Clearance type
Traditional
Product code
LRG
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

No recalls on record reference this clearance.

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