PROGESTERONE TEST SET 125I 17-OH— 510(k) K834246
Substantially EquivalentWien Laboratories, Inc.
FDA 510(k) clearance K834246 for PROGESTERONE TEST SET 125I 17-OH, Substantially Equivalent on 1984-02-04. Applicant: Wien Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Wien Laboratories, Inc.
- Product code
- Code JLX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1395
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JLX
view all- K100682 — GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
- K081922 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
- K062534 — ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
- K060452 — ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
- K050960 — MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
More clearances from Wien Laboratories, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.