ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE— 510(k) K062534
Substantially EquivalentDrg Intl., Inc.
FDA 510(k) clearance K062534 for ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE, Substantially Equivalent on 2008-01-29. Applicant: Drg Intl., Inc.. Device class: 1.
Clearance details
- Applicant
- Drg Intl., 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
- East Stroudsburg, PA, US
Recent devices under product code JLX
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- K050960 — MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
- K042424 — DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
More clearances from Drg Intl., Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.