OSTEOMARK(R)— 510(k) K945946

Substantially Equivalent

Ostex Intl., Inc.

FDA 510(k) clearance K945946 for OSTEOMARK(R), Substantially Equivalent on 1995-05-08. Applicant: Ostex Intl., Inc.. Device class: 1.

Clearance details

Applicant: Ostex Intl., Inc.
Product code: Code JMM
Device class: Class 1
Regulation: 21 CFR 862.1400
Advisory panel: Clinical Chemistry
Date received: 1994-12-05
Decision date: 1995-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JMM

K011052 — OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE2001-07-30
K993706 — ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY2000-07-24
K992997 — OSTEOMARK NTX POC1999-11-09
K990843 — SERUM CROSSLAPS ONE STEP ELISA1999-07-09
K983457 — OSTEOMARK NTX SERUM EIA1999-02-02

More clearances from Ostex Intl., Inc.

K980518 — OSTEOMARK1998-03-06
K961562 — OSTEOMARK1996-07-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.