CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT— 510(k) K820341

Name: FDA 510(k) clearance K820341
Creator: U.S. Food and Drug Administration
Published: 1982-03-04

Substantially Equivalent

E. R. Squibb & Sons, Inc.

FDA 510(k) clearance K820341 for CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1982-03-04. Applicant: E. R. Squibb & Sons, Inc.. Device class: 2.

Clearance details

Applicant: E. R. Squibb & Sons, Inc.
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1982-02-08
Decision date: 1982-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGR

view all

K242190 — Access Cortisol; DxC 500i Clinical Analyzer2025-03-05
K223038 — Access Cortisol2023-02-08
K202136 — IDS Cortisol2021-04-13
K202826 — IMMULITE® 2000 Cortisol2021-01-15
K203270 — IMMULITE/IMMULITE® 1000 Cortisol2021-01-15

More clearances from E. R. Squibb & Sons, Inc.

view all

K821494 — RIA STAT 161982-06-03
K820616 — ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY1982-03-26
K820340 — T3 UPTAKE-SQUIBB DIAGNOSTIC KIT1982-03-04
K811240 — SUR-FIT LOOP OSTOMY O.R. SET1981-06-16
K811239 — SUR-FIT DISPOSABLE CONVEX INSERT1981-06-09

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