ATAC 2000 CHEMISTRY ANALYZER— 510(k) K851321

Name: FDA 510(k) clearance K851321
Creator: U.S. Food and Drug Administration
Published: 1985-04-25

Substantially Equivalent

Turpen Laboratory Systems, Inc.

FDA 510(k) clearance K851321 for ATAC 2000 CHEMISTRY ANALYZER, Substantially Equivalent on 1985-04-25. Applicant: Turpen Laboratory Systems, Inc.. Device class: 1.

Clearance details

Applicant: Turpen Laboratory Systems, Inc.
Product code: Code JQP
Device class: Class 1
Regulation: 21 CFR 862.2100
Advisory panel: Clinical Chemistry
Date received: 1985-04-02
Decision date: 1985-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jackson, NJ, 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.