THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE— 510(k) K024031
Substantially EquivalentTheratest Laboratories, Inc.
FDA 510(k) clearance K024031 for THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE, Substantially Equivalent on 2003-02-06. Applicant: Theratest Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Theratest Laboratories, Inc.
- Product code
- Code LJM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lombard, IL, US
Recent devices under product code LJM
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Data sourced from openFDA. This site is unofficial and independent of the FDA.