PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT— 510(k) K862483

Name: FDA 510(k) clearance K862483
Creator: U.S. Food and Drug Administration
Published: 1987-01-14

Substantially Equivalent

Pantex, Div. Bio-Analysis, Inc.

FDA 510(k) clearance K862483 for PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1987-01-14. Applicant: Pantex, Div. Bio-Analysis, Inc.. Device class: 1.

Clearance details

Applicant: Pantex, Div. Bio-Analysis, Inc.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 1986-06-30
Decision date: 1987-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDZ

view all

K252728 — IDS-iSYS Total Testosterone2026-04-15
K240865 — IDS-iSYS Free Testosterone2024-10-23
K233480 — Access SHBG2024-02-08
K223405 — Access Testosterone2023-01-13
K211685 — Elecsys Testosterone II2022-05-06

More clearances from Pantex, Div. Bio-Analysis, Inc.

view all

K102841 — PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY2012-05-08
K942658 — NEOSCREEN ELISA TSH1995-02-24
K914107 — PROLACTIN IRMA IMMUNOMAG1991-09-30
K912804 — FSH IRMA IMMUNOMAG1991-08-12
K911839 — NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT1991-06-18

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