SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM— 510(k) K012221

Substantially Equivalent

Biosafe Laboratories, Inc.

FDA 510(k) clearance K012221 for SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM, Substantially Equivalent on 2002-04-03. Applicant: Biosafe Laboratories, Inc..

Clearance details

Applicant: Biosafe Laboratories, Inc.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2001-07-16
Decision date: 2002-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, 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.