GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415— 510(k) K901832

Name: FDA 510(k) clearance K901832
Creator: U.S. Food and Drug Administration
Published: 1990-07-09

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K901832 for GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415, Substantially Equivalent on 1990-07-09. Applicant: Amersham Corp.. Device class: 2.

Clearance details

Applicant: Amersham Corp.
Product code: Code KGI
Device class: Class 2
Regulation: 21 CFR 892.1170
Advisory panel: Radiology
Date received: 1990-04-24
Decision date: 1990-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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K912766 — AMERLITE CK-MB ASSAY1991-07-17
K904666 — AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/20081990-11-02
K902760 — AMERSHAM TSH CONTROL SERA1990-07-27

Adverse events under product code KGI

product code KGI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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