DRG SLV TESTOSTERONE ELISA TEST— 510(k) K052649
Substantially EquivalentDrg Intl., Inc.
FDA 510(k) clearance K052649 for DRG SLV TESTOSTERONE ELISA TEST, Substantially Equivalent on 2006-01-27. Applicant: Drg Intl., Inc.. Device class: 1.
Clearance details
- Applicant
- Drg Intl., Inc.
- Product code
- Code CDZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1680
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Stroudsburg, PA, US
Recent devices under product code CDZ
view allMore clearances from Drg Intl., Inc.
view allRecalls naming K052649
K-number listed on FDA's recall record- Z-2622-2024 — 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 saliva.
- Z-2159-2019 — 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 the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052649.
Data sourced from openFDA. This site is unofficial and independent of the FDA.