THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120— 510(k) K090760
Substantially EquivalentTheratest Laboratories, Inc.
FDA 510(k) clearance K090760 for THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120, Substantially Equivalent on 2009-09-03. Applicant: Theratest Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Theratest Laboratories, Inc.
- Product code
- Code JZO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5870
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lombard, IL, US
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