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510(k) K011143

TINA-QUANT D-DIMER TEST SYSTEM by Roche Diagnostics Corp. — Product Code GHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2001
Date Received
April 13, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrin Split Products
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

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Other clearances for product code GHH

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  • K021877 — MDA D-DIMER (August 7, 2002)
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  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K945642 — AGEN DIMERTEST GOLD EIA (October 25, 1995)