Atlas FDA

BS-200 CHEMISTRY ANALYZER, MODE BS-200

FDA 510(k) clearance K072018 · decided 2008-02-01

Clearance details

K-number
K072018
Device name
BS-200 CHEMISTRY ANALYZER, MODE BS-200
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Decision
Substantially Equivalent
Date received
2007-07-23
Decision date
2008-02-01
Days to decision
193 days
Clearance type
Traditional
Product code
CFR
Device class
2
Regulation number
862.1345
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Great Neck, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BS-200 Chemistry Analyzer Designed for clinical laboratory use. recall (Z-0977-2013)Mindray DS USA, Inc. d.b.a. Mindray North America2013-03-22