HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2— 510(k) K040359

Name: FDA 510(k) clearance K040359
Creator: U.S. Food and Drug Administration
Published: 2004-03-19

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K040359 for HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2, Substantially Equivalent on 2004-03-19. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code JPA
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2004-02-13
Decision date: 2004-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

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.