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510(k) K952026

PYRILINKS POLYCLONAL ASSAY KIT by Metra Biosystems, Inc. — Product Code JMM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1995
Date Received
May 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Column Chromatography & Color Development, Hydroxyproline
Device Class
Class I
Regulation Number
862.1400
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)
  • K952506 — PYRILINKS ASSAY KIT (November 3, 1995)
  • K952768 — ALKPHASE-B ASSAY KIT (August 24, 1995)

Other clearances for product code JMM

  • K011052 — OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE (July 30, 2001)
  • K993706 — ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY (July 24, 2000)
  • K992997 — OSTEOMARK NTX POC (November 9, 1999)
  • K990843 — SERUM CROSSLAPS ONE STEP ELISA (July 9, 1999)
  • K983457 — OSTEOMARK NTX SERUM EIA (February 2, 1999)
  • K983674 — VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROL (January 29, 1999)
  • K972788 — CROSSLAPS ELISA (December 22, 1998)
  • K981364 — PYRILINKS-D ASSAY KIT (August 13, 1998)
  • K980833 — IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 (May 1, 1998)
  • K980518 — OSTEOMARK (March 6, 1998)