THERATEST LAB, INC., EL-ANASCR KIT— 510(k) K954106
Substantially EquivalentTheratest Laboratories, Inc.
FDA 510(k) clearance K954106 for THERATEST LAB, INC., EL-ANASCR KIT, Substantially Equivalent on 1995-11-14. 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
- Chicago, IL, US
Recent devices under product code LJM
view allMore clearances from Theratest Laboratories, Inc.
view all- K090753 — THERATEST EL-ANTI-CCP/2
- K090760 — THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
- K071692 — THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
- K061376 — EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
- K060176 — EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
Data sourced from openFDA. This site is unofficial and independent of the FDA.