AO-10 AUTOMATED OSMOMETER— 510(k) K843997

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K843997 for AO-10 AUTOMATED OSMOMETER, Substantially Equivalent on 1984-10-31. Applicant: bioMerieux, Inc.. Device class: 1.

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code JJM
Device class: Class 1
Regulation: 21 CFR 862.2730
Advisory panel: Clinical Chemistry
Date received: 1984-10-11
Decision date: 1984-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ivyland, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJM

K965036 — THE ADVANCED OSMOMETER (3900)1997-02-20
K962056 — ADVANCED MICRO-OSMOMETER MODEL 33001996-07-11
K925970 — MODEL 3D3 OSMOMETER1993-07-09
K911092 — OSMOMETER MODEL 24001991-05-22
K873642 — OSMOMETER MODEL 1101987-10-20

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