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510(k) K945946

OSTEOMARK(R) by Ostex Intl., Inc. — Product Code JMM

K945946 is an FDA 510(k) premarket notification submitted by Ostex Intl., Inc. for the device "OSTEOMARK(R)". The FDA issued a decision of Substantially Equivalent on May 8, 1995. The device falls under product code JMM (Column Chromatography & Color Development, Hydroxyproline), a Class I device regulated under 21 CFR 862.1400. Ostex Intl., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1995
Date Received
December 5, 1994
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.

  • K011052 — OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE (July 30, 2001)
  • K983457 — OSTEOMARK NTX SERUM EIA (February 2, 1999)
  • K980518 — OSTEOMARK (March 6, 1998)
  • K961562 — OSTEOMARK (July 11, 1996)

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