COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT— 510(k) K860335
Substantially EquivalentDiagnostic Products Corp.
FDA 510(k) clearance K860335 for COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT, Substantially Equivalent on 1986-04-24. Applicant: Diagnostic Products Corp.. Device class: 1.
Clearance details
- Applicant
- Diagnostic Products Corp.
- 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
- Los Angeles, CA, 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 Diagnostic Products Corp.
view all- K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
- K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
- K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
- K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
- K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.