CYTOTECH CIC ENZYME IMMUNOASSAY— 510(k) K862649
Substantially EquivalentCytotech, Inc.
FDA 510(k) clearance K862649 for CYTOTECH CIC ENZYME IMMUNOASSAY, Substantially Equivalent on 1986-09-04. Applicant: Cytotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Cytotech, Inc.
- Product code
- Code DAK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5240
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code DAK
view allMore clearances from Cytotech, Inc.
view allRecalls naming K862649
K-number listed on FDA's recall record- Z-1496-2018 — MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (¿g Eq/ml) can be determined by comparison to a standard curve.
- Z-1497-2018 — MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K862649.
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