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510(k) K952768

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1995
Date Received
June 14, 1995
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)
  • K981373 — ALKPHASE-B ASSAY KIT (May 27, 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)

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  • K020625 — SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 (May 6, 2002)
  • K011113 — HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PA (June 13, 2001)
  • K994278 — ACCESS OSTASE IMMUNOENZYMETRIC ASSAY (March 28, 2000)
  • K981373 — ALKPHASE-B ASSAY KIT (May 27, 1998)
  • K972666 — TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY (September 11, 1997)
  • K964764 — OPUS BONE ALP (January 24, 1997)
  • K961573 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (August 19, 1996)