OSTEOMARK— 510(k) K961562

Substantially Equivalent

Ostex Intl., Inc.

FDA 510(k) clearance K961562 for OSTEOMARK, Substantially Equivalent on 1996-07-11. 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: 1996-04-22
Decision date: 1996-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JMM

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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
K945946 — OSTEOMARK(R)1995-05-08

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