ERYTHROPOIETIN IMMUNOASSAY KIT— 510(k) K952559
Substantially EquivalentNichols Institute
FDA 510(k) clearance K952559 for ERYTHROPOIETIN IMMUNOASSAY KIT, Substantially Equivalent on 1996-05-29. Applicant: Nichols Institute. Device class: 2.
Clearance details
- Applicant
- Nichols Institute
- 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
view all- K952505 — INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)
- K946247 — IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3
- K950524 — NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY
- K932650 — ERYTHROPOIETIN IMMUNOASSAY KIT
- K931600 — CHEMILUMINESCENCE FREE T3 IMMUNOASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.