ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM— 510(k) K863679
Substantially EquivalentNichols Institute Diagnostics
FDA 510(k) clearance K863679 for ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM, Substantially Equivalent on 1986-10-16. Applicant: Nichols Institute Diagnostics. Device class: 1.
Clearance details
- Applicant
- Nichols Institute Diagnostics
- Product code
- Code CEP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1485
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code CEP
view allMore clearances from Nichols Institute Diagnostics
view all- K050784 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY
- K042676 — NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
- K042689 — NICHOLS ADVANTAGE CORTISOL
- K040813 — NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
- K033727 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.