INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)— 510(k) K952505

Name: FDA 510(k) clearance K952505
Creator: U.S. Food and Drug Administration
Published: 1995-07-03

Substantially Equivalent

Nichols Institute

FDA 510(k) clearance K952505 for INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA), Substantially Equivalent on 1995-07-03. Applicant: Nichols Institute. Device class: 1.

Clearance details

Applicant: Nichols Institute
Product code: Code CFL
Device class: Class 1
Regulation: 21 CFR 862.1370
Advisory panel: Clinical Chemistry
Date received: 1995-05-31
Decision date: 1995-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CFL

view all

K972761 — SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY1997-09-25
K971353 — DSL ACTIVE NON-EXTRACTION IGF-I ELISA1997-05-12
K970701 — DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)1997-04-02
K962758 — DSL 9100 IGF-II IRMA1996-08-30
K961678 — HUMAN GROWTH HORMONE IMMUNOASSAY KIT1996-07-08

More clearances from Nichols Institute

view all

K952559 — ERYTHROPOIETIN IMMUNOASSAY KIT1996-05-29
K946247 — IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-31995-06-23
K950524 — NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY1995-05-15
K932650 — ERYTHROPOIETIN IMMUNOASSAY KIT1994-03-11
K931600 — CHEMILUMINESCENCE FREE T3 IMMUNOASSAY1993-09-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.