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510(k) K030826

PRECISET DAT AMPHETAMINE by Quantimetrix Corp. — Product Code DIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2003
Date Received
March 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lead, Delta Amino Levulinic Acid
Device Class
Class II
Regulation Number
862.3550
Review Panel
TX
Submission Type

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  • K021393 — PRECISET DAT PLUS (June 13, 2002)
  • K013662 — MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS (March 8, 2002)
  • K010337 — LIPOPRINT SYSTEM, LDL SUBFRACTIONS (July 25, 2001)

Other clearances for product code DIJ

  • K792407 — ELVI-AMINOLEVULINIC ACID (January 16, 1980)