IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS— 510(k) K852676

Substantially Equivalent

Allied Instrumentation Laboratory

FDA 510(k) clearance K852676 for IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS, Substantially Equivalent on 1985-07-22. Applicant: Allied Instrumentation Laboratory.

Clearance details

Applicant
Allied Instrumentation Laboratory
Product code
Code CHL
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lexington, MA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CHL

product code CHL
Death
20
Malfunction
999
Total
1,019

Source: openFDA MAUDE database, through . 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.