SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM— 510(k) K012221
Substantially EquivalentBiosafe 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.. Device class: 2.
Clearance details
- Applicant
- Biosafe Laboratories, Inc.
- Product code
- Code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, IL, US
Recent devices under product code JKA
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More clearances from Biosafe Laboratories, Inc.
view all- K042379 — ANEMIAPRO SELF-SCREENER
- K011970 — BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
- K011525 — SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)
- K003752 — BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)
- K991850 — SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
Adverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
Source: openFDA MAUDE database, through . 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.