SEROZYME CORTISOL TEST KIT— 510(k) K903975

Name: FDA 510(k) clearance K903975
Creator: U.S. Food and Drug Administration
Published: 1991-01-23

Substantially Equivalent

Serono-Baker Diagnostics, Inc.

FDA 510(k) clearance K903975 for SEROZYME CORTISOL TEST KIT, Substantially Equivalent on 1991-01-23. Applicant: Serono-Baker Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Serono-Baker Diagnostics, Inc.
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1990-08-28
Decision date: 1991-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, 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 Serono-Baker Diagnostics, Inc.

view all

K924257 — TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY1992-11-30
K914886 — SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)1992-03-02
K915164 — SRI TESTOSTERONE ENZYME IMMUNOASSAY1992-03-02
K915602 — SRI DIGOXIN ENZYME IMMUNOASSAY1992-01-17
K912937 — SR1 FREE T4 ENZYME IMMUNOASSAY1991-11-19

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