AMYLOCHROME STAT SEPARATOR, TEST— 510(k) K790485

Substantially Equivalent

Hoffmann-La Roche, Inc.

FDA 510(k) clearance K790485 for AMYLOCHROME STAT SEPARATOR, TEST, Substantially Equivalent on 1979-05-03. Applicant: Hoffmann-La Roche, Inc..

Clearance details

Applicant: Hoffmann-La Roche, Inc.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 1979-03-12
Decision date: 1979-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.