510(k) K994338 ยท DHR System, Test, Rheumatoid Factor
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
| Applicant | Cogent Diagnotics , Ltd., Midlothian, Scotland, GB |
| Decision | Substantially Equivalent, Feb 3, 2000 |
| Received | Dec 23, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994338
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2018 | Hycor Biomedical Inc 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 AUT Open, Classified |
DHR | None listed |
| Feb 21, 2018 | Hycor Biomedical Inc 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: Completed |
DHR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.