THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR— 510(k) K092757
Substantially EquivalentThera-Test Laboratories, Inc.
FDA 510(k) clearance K092757 for THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR, Substantially Equivalent on 2009-10-09. Applicant: Thera-Test Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Thera-Test Laboratories, Inc.
- Product code
- Code MSV
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lombard, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.