CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3— 510(k) K011548
Substantially EquivalentMedical Analysis Systems, Inc.
FDA 510(k) clearance K011548 for CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3, Substantially Equivalent on 2001-06-18. Applicant: Medical Analysis Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Medical Analysis Systems, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Camarillo, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.