KING DIAGNOSTICS CHOLESTEROL-FE TEST— 510(k) K811746

Name: FDA 510(k) clearance K811746
Creator: U.S. Food and Drug Administration
Published: 1981-07-10

Substantially Equivalent

King Diagnostics, Inc.

FDA 510(k) clearance K811746 for KING DIAGNOSTICS CHOLESTEROL-FE TEST, Substantially Equivalent on 1981-07-10. Applicant: King Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: King Diagnostics, Inc.
Product code: Code CHO
Device class: Class 2
Regulation: 21 CFR 862.1230
Advisory panel: Clinical Chemistry
Date received: 1981-06-22
Decision date: 1981-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHO

view all

K860253 — AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)1986-03-14
K844135 — PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU1985-03-05
K841478 — RIANEN CYCLIC-AMP RADIOIMMUNOASSAY1984-06-14
K823504 — CYCLIC ADENOSINE MONOPHOSHATE BY RADIO1983-01-28
K811273 — CYCLIC AMP RADIOIMMUNOASSAY KIT [125I]1981-05-27

More clearances from King Diagnostics, Inc.

view all

K933329 — KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT1993-10-22
K931834 — KING SODIUM/POTASSIUM STANDARD MODIFIED1993-08-25
K931773 — HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)1993-08-16
K931326 — KING DIAGNOSTICS CK REAGENT1993-06-15
K923129 — KING DIAGNOSTICS GLUCOSE (HK) REAGENT1992-11-02

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