AUTOSTAT II RHEUMATOID FACTOR IGM ELISA— 510(k) K994338
Substantially EquivalentCogent Diagnotics , Ltd.
FDA 510(k) clearance K994338 for AUTOSTAT II RHEUMATOID FACTOR IGM ELISA, Substantially Equivalent on 2000-02-03. Applicant: Cogent Diagnotics , Ltd.. Device class: 2.
Clearance details
- Applicant
- Cogent Diagnotics , Ltd.
- Product code
- Code DHR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Midlothian, Scotland, GB
Recent devices under product code DHR
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view allRecalls naming K994338
K-number listed on FDA's recall record- Z-2200-2019 — HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.
- Z-2134-2019 — AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K994338.
Data sourced from openFDA. This site is unofficial and independent of the FDA.