SOMATOMEDIN C BY RADIOIMMUNOASSAY— 510(k) K850892

Name: FDA 510(k) clearance K850892
Creator: U.S. Food and Drug Administration
Published: 1985-06-06

Substantially Equivalent

Immuno Nuclear Corp.

FDA 510(k) clearance K850892 for SOMATOMEDIN C BY RADIOIMMUNOASSAY, Substantially Equivalent on 1985-06-06. Applicant: Immuno Nuclear Corp.. Device class: 1.

Clearance details

Applicant: Immuno Nuclear Corp.
Product code: Code CFL
Device class: Class 1
Regulation: 21 CFR 862.1370
Advisory panel: Clinical Chemistry
Date received: 1985-03-04
Decision date: 1985-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, 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 Immuno Nuclear Corp.

view all

K863743 — BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT1986-12-15
K863973 — ELM ALLERGEN DISC1986-12-01
K863844 — IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC1986-10-29
K863123 — IMMUNO BIOTECH MUGWART ALLERGEN DISC1986-10-01
K863098 — MEADOW FESCUE ALLERGEN DISC1986-09-15

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