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510(k) K952320

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

K952320 is an FDA 510(k) premarket notification submitted by Metra Biosystems, Inc. for the device "PYRILINKS-D ASSAY KIT". The FDA issued a decision of Substantially Equivalent on December 29, 1995. The device falls under product code JMM (Column Chromatography & Color Development, Hydroxyproline), a Class I device regulated under 21 CFR 862.1400. Metra Biosystems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1995
Date Received
May 18, 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)
  • K952506 — PYRILINKS ASSAY KIT (November 3, 1995)
  • K952026 — PYRILINKS POLYCLONAL 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)

FDA data resources