EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3— 510(k) K061376
Substantially EquivalentTheratest Laboratories, Inc.
FDA 510(k) clearance K061376 for EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3, Substantially Equivalent on 2006-07-20. Applicant: Theratest Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Theratest Laboratories, Inc.
- Product code
- Code MOB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lombard, IL, US
Recent devices under product code MOB
view all- K261466 — Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM
- K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
- K172582 — EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern
- K172461 — AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
- K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
More clearances from Theratest Laboratories, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.