DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600— 510(k) K001574
Substantially EquivalentAxis-Shield
FDA 510(k) clearance K001574 for DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600, Substantially Equivalent on 2000-06-09. Applicant: Axis-Shield. Device class: 2.
Clearance details
- Applicant
- Axis-Shield
- Product code
- Code MID
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dundee Tayside, Scotland, GB
Recent devices under product code MID
view allRecalls naming K001574
K-number listed on FDA's recall record- Z-2920-2018 — is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders
- Z-2921-2018 — is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001574.
Data sourced from openFDA. This site is unofficial and independent of the FDA.