ANDROSTENEDIONE TEST SET 125I— 510(k) K832452

Name: FDA 510(k) clearance K832452
Creator: U.S. Food and Drug Administration
Published: 1983-09-12

Substantially Equivalent

Wien Laboratories, Inc.

FDA 510(k) clearance K832452 for ANDROSTENEDIONE TEST SET 125I, Substantially Equivalent on 1983-09-12. Applicant: Wien Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Wien Laboratories, Inc.
Product code: Code CIZ
Device class: Class 1
Regulation: 21 CFR 862.1075
Advisory panel: Clinical Chemistry
Date received: 1983-07-25
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CIZ

view all

K963002 — ACTIVE ANDROSTENEDIONE EIA1996-08-16
K954755 — COAT-A-COUNT DIRECT ANDROSTENEDIONE1995-11-29
K934751 — ACTIVE ANDROSTANEDIOL GLUCURONIDE1994-01-10
K860559 — ANDROSTENEDIONE 125I KIT BY RIA1986-03-14
K854673 — DSL ANDROSTENEDIONE RIA (DSL # 4200)1986-01-22

More clearances from Wien Laboratories, Inc.

view all

K912850 — SHBG1991-08-12
K834246 — PROGESTERONE TEST SET 125I 17-OH1984-02-04
K823200 — 125 I-DEHYDROEPIANDROSTERONE SULFATE1982-11-29
K821652 — DOXEPIN TRI-CY TEST SET1982-06-14
K821653 — PROTRIPTYLINE TRI-CY TEST SET1982-06-14

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