SMARTPREP CENTRIFUGE SYSTEM— 510(k) K991430

Substantially Equivalent

Harvest Technologies, LLC

FDA 510(k) clearance K991430 for SMARTPREP CENTRIFUGE SYSTEM, Substantially Equivalent on 1999-05-28. Applicant: Harvest Technologies, LLC.

Clearance details

Applicant: Harvest Technologies, LLC
Product code: Code JQC
Advisory panel: Clinical Chemistry
Date received: 1999-04-26
Decision date: 1999-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

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Adverse events under product code JQC

product code JQC

Other: 1
Total: 1

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.