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510(k) K011052

OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE by Ostex Intl., Inc. — Product Code JMM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2001
Date Received
April 6, 2001
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 Ostex Intl., Inc.

  • K983457 — OSTEOMARK NTX SERUM EIA (February 2, 1999)
  • K980518 — OSTEOMARK (March 6, 1998)
  • K961562 — OSTEOMARK (July 11, 1996)
  • K945946 — OSTEOMARK(R) (May 8, 1995)

Other clearances for product code JMM

  • 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)
  • K974260 — PYRILINKS-D ASSAY KIT (January 26, 1998)