Cleared Traditional

OSTEOMARK NTX POC

K992997 · Metrika, Inc. · Chemistry
Nov 1999
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K992997 is an FDA 510(k) clearance for the OSTEOMARK NTX POC, a Column Chromatography & Color Development, Hydroxyproline (Class I — General Controls, product code JMM), submitted by Metrika, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 9, 1999, 63 days after receiving the submission on September 7, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1400.

Submission Details

510(k) Number K992997 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 1999
Decision Date November 09, 1999
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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