510(k) K942610 ยท LFM Enzyme Immunoassay, Digitoxin
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, Oct 20, 1994 |
| Received | Jun 2, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942610
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | QUIDEL ORTHO Brand Name: VITROS Chemistry Products
Product Name: VITROS Chemistry Products DGXN Slides
Model/Catalog Number: 8343386
Software Version: Not Applicable
Product Description: The VITROS DGXN Slide is a Open, Classified |
LFM | None listed |
| Jan 10, 2025 | QUIDEL ORTHO Brand Name: VITROS Chemistry Products
Product Name: VITROS Chemistry Products DGXN Slides
Model/Catalog Number: 8343386
Software Version: Not Applicable
Product Description: The VITROS DGXN Slide is a Open, Classified |
LFM | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386
VITROS DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/950/5,1 FS Terminated |
LFM | None listed |
| Aug 15, 2012 | Ortho-Clinical Diagnostics VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package.
Product Usage: Inten Terminated |
LFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.