QAP MICROCOMPUTER SYSTEM— 510(k) K823110

Name: FDA 510(k) clearance K823110
Creator: U.S. Food and Drug Administration
Published: 1982-11-16

Substantially Equivalent

American Dade

FDA 510(k) clearance K823110 for QAP MICROCOMPUTER SYSTEM, Substantially Equivalent on 1982-11-16. Applicant: American Dade. Device class: 1.

Clearance details

Applicant: American Dade
Product code: Code JQP
Device class: Class 1
Regulation: 21 CFR 862.2100
Advisory panel: Clinical Chemistry
Date received: 1982-10-21
Decision date: 1982-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-14
K872789 — PARAMAX URINE/CSF CALIBRATOR1987-09-02
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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.