Atlas FDA

ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2

FDA 510(k) clearance K033009 · decided 2003-10-16

Clearance details

K-number
K033009
Device name
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2003-09-26
Decision date
2003-10-16
Days to decision
20 days
Clearance type
Special
Product code
CIX
Device class
2
Regulation number
862.1035
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

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