SERUM 11-DESOXYCORTISOL I AS TRACER— 510(k) K791740

Name: FDA 510(k) clearance K791740
Creator: U.S. Food and Drug Administration
Published: 1979-09-27

Substantially Equivalent

Radioassay Systems Laboratories, Inc.

FDA 510(k) clearance K791740 for SERUM 11-DESOXYCORTISOL I AS TRACER, Substantially Equivalent on 1979-09-27. Applicant: Radioassay Systems Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Radioassay Systems Laboratories, Inc.
Product code: Code JKB
Device class: Class 1
Regulation: 21 CFR 862.1185
Advisory panel: Clinical Chemistry
Date received: 1979-09-10
Decision date: 1979-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

More clearances from Radioassay Systems Laboratories, Inc.

view all

K862204 — RSL (125I) ALDOSTERONE KIT1986-09-25
K842960 — ANDROSTENEDIONE BY RIA1984-09-27
K840886 — HYDROXYPROGESTERONE BY RIA 17A1984-04-18
K831855 — HATCH KIT1983-07-28
K802195 — DEHYDROEPIANDROSTERONE SULFATE KIT RIA1980-10-23

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