THERATEST EL-ANTI-CCP/2— 510(k) K090753
Substantially EquivalentTheratest Laboratories, Inc.
FDA 510(k) clearance K090753 for THERATEST EL-ANTI-CCP/2, Substantially Equivalent on 2010-03-05. Applicant: Theratest Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Theratest Laboratories, Inc.
- Product code
- Code NHX
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lombard, IL, US
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More clearances from Theratest Laboratories, Inc.
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- K061376 — EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
- K060176 — EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
- K051066 — THERATEST EL-ANA PROFILES
Data sourced from openFDA. This site is unofficial and independent of the FDA.