510(k) K052649 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
DRG SLV TESTOSTERONE ELISA TEST
| Applicant | Drg Intl., Inc., East Stroudsburg PA, US |
| Decision | Substantially Equivalent, Jan 27, 2006 |
| Received | Sep 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052649
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2024 | DRG International, Inc. Product Name: Salivary Testosterone ELISA
Model/Catalog Number: SLV-3013
Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in Open, Classified |
CDZ | None listed |
| May 21, 2019 | DRG Instruments GmbH DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva
Catalog # SLV-3013
Product Usage:
The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for th Terminated |
CDZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.