BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM— 510(k) K011970
Substantially EquivalentBiosafe Laboratories, Inc.
FDA 510(k) clearance K011970 for BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM, Substantially Equivalent on 2001-09-26. Applicant: Biosafe Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Biosafe Laboratories, Inc.
- Product code
- Code CHH
- Device class
- Class 1
- Regulation
- 21 CFR 862.1175
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, IL, US
Recent devices under product code CHH
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- K003752 — BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)
- K991850 — SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
Data sourced from openFDA. This site is unofficial and independent of the FDA.