Cleared Traditional

OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE

K011052 · Ostex Intl., Inc. · Chemistry
Jul 2001
Decision
115d
Days
Class 1
Risk

About This 510(k) Submission

K011052 is an FDA 510(k) clearance for the OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE, 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 July 30, 2001, 115 days after receiving the submission on April 6, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1400.

Submission Details

510(k) Number K011052 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2001
Decision Date July 30, 2001
Days to Decision 115 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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