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510(k) K021877

MDA D-DIMER by bioMerieux, Inc. — Product Code GHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2002
Date Received
June 7, 2002
Clearance Type
Traditional
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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  • K993276 — SIMPLIFY D-DIMER, MODEL DCGK1 (December 14, 1999)
  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K945642 — AGEN DIMERTEST GOLD EIA (October 25, 1995)