Cleared Traditional

OSTEOMARK NTX SERUM EIA

K983457 · Ostex Intl., Inc. · Chemistry
Feb 1999
Decision
125d
Days
Class 1
Risk

About This 510(k) Submission

K983457 is an FDA 510(k) clearance for the OSTEOMARK NTX SERUM EIA, a Column Chromatography & Color Development, Hydroxyproline (Class I — General Controls, product code JMM), submitted by Ostex Intl., Inc. (Seattle, US). The FDA issued a Cleared decision on February 2, 1999, 125 days after receiving the submission on September 30, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1400.

Submission Details

510(k) Number K983457 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1998
Decision Date February 02, 1999
Days to Decision 125 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JMM — Column Chromatography & Color Development, Hydroxyproline
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1400

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