API MDS*— 510(k) K823785

Name: FDA 510(k) clearance K823785
Creator: U.S. Food and Drug Administration
Published: 1983-01-09

Substantially Equivalent

Analytical Products, Inc.

FDA 510(k) clearance K823785 for API MDS*, Substantially Equivalent on 1983-01-09. Applicant: Analytical Products, Inc.. Device class: 1.

Clearance details

Applicant: Analytical Products, Inc.
Product code: Code JQP
Device class: Class 1
Regulation: 21 CFR 862.2100
Advisory panel: Clinical Chemistry
Date received: 1982-12-16
Decision date: 1983-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JQP

product code JQP

Death: 3
Malfunction: 690
Total: 693

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.