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510(k) K981373

ALKPHASE-B ASSAY KIT by Metra Biosystems, Inc. — Product Code CIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1998
Date Received
April 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

Other clearances by Metra Biosystems, Inc.

  • K981364 — PYRILINKS-D ASSAY KIT (August 13, 1998)
  • K974260 — PYRILINKS-D ASSAY KIT (January 26, 1998)
  • K952320 — PYRILINKS-D ASSAY KIT (December 29, 1995)
  • K952026 — PYRILINKS POLYCLONAL ASSAY KIT (November 3, 1995)
  • K952506 — PYRILINKS ASSAY KIT (November 3, 1995)
  • K952768 — ALKPHASE-B ASSAY KIT (August 24, 1995)

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  • K952768 — ALKPHASE-B ASSAY KIT (August 24, 1995)