Atlas FDA

Optilite IgG4 Kit

FDA 510(k) clearance K150526 · decided 2015-05-30

Clearance details

K-number
K150526
Device name
Optilite IgG4 Kit
Applicant
The Binding Site Group , Ltd.
Decision
Substantially Equivalent
Date received
2015-03-02
Decision date
2015-05-30
Days to decision
89 days
Clearance type
Traditional
Product code
CFN
Device class
2
Regulation number
866.5510
Medical specialty
Immunology
Advisory committee
Immunology
Location
Birmingham, GB
Third-party review
No
Expedited review
No

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DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (K162208)Beckman Coulter, Inc.2017-01-09
The Optilite IgG3 kit (K142735)The Binding Site Group , Ltd.2014-12-21
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER (K130122)Beckman Coulter, Inc.2014-01-07
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Recalls involving this device

No recalls on record reference this clearance.