Home / 510(k) Clearances / K032535

510(k) K032535

MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM by Roche Diagnostics Corp. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2003
Date Received
August 18, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

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