NORDICLAB ESTRADIOL RIA TEST— 510(k) K800920
Substantially EquivalentNordiclab Intl.
FDA 510(k) clearance K800920 for NORDICLAB ESTRADIOL RIA TEST, Substantially Equivalent on 1980-05-14. Applicant: Nordiclab Intl.. Device class: 1.
Clearance details
- Applicant
- Nordiclab Intl.
- Product code
- Code CHP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1260
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code CHP
view all- K041349 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
- K973901 — 17 B-ESTRADIOL (ELISA)
- K973743 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- K970386 — ACS ESTADIOL-6 II
- K970643 — VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
More clearances from Nordiclab Intl.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.