ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY— 510(k) K980737
Substantially EquivalentNichols Institute Diagnostics
FDA 510(k) clearance K980737 for ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY, Substantially Equivalent on 1999-03-23. Applicant: Nichols Institute Diagnostics. Device class: 2.
Clearance details
- Applicant
- Nichols Institute Diagnostics
- Product code
- Code GGT
- Device class
- Class 2
- Regulation
- 21 CFR 864.7250
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Juan Capistrano, CA, US
Recent devices under product code GGT
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.