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510(k) K981364

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1998
Date Received
April 15, 1998
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.

  • 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)
  • 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)
  • K980833 — IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 (May 1, 1998)
  • K980518 — OSTEOMARK (March 6, 1998)
  • K974260 — PYRILINKS-D ASSAY KIT (January 26, 1998)