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510(k) K040431

ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 by Roche Diagnostics Corp. — Product Code DAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2004
Date Received
February 19, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igm (Mu Chain Specific), Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

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Other clearances for product code DAO

  • K982639 — SPIFE URINE IFE (November 4, 1998)
  • K955908 — BOEHRINGER MANNHEIM IGM ASSAY (February 9, 1996)
  • K850586 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M (March 14, 1985)
  • K841992 — MODIFICATION TO ACS CORONARY GUIDING (June 11, 1984)
  • K812487 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM (September 23, 1981)
  • K800450 — GEMENI IGM ASSAY (April 24, 1980)
  • K790705 — ANTISERUM TO HUMAN IGM (April 12, 1979)