OSTEOMARK NTX SERUM EIA— 510(k) K983457

Substantially Equivalent

Ostex Intl., Inc.

FDA 510(k) clearance K983457 for OSTEOMARK NTX SERUM EIA, Substantially Equivalent on 1999-02-02. 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: 1998-09-30
Decision date: 1999-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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