RIANEN CYCLIC-AMP RADIOIMMUNOASSAY— 510(k) K841478

Name: FDA 510(k) clearance K841478
Creator: U.S. Food and Drug Administration
Published: 1984-06-14

Substantially Equivalent

New England Nuclear

FDA 510(k) clearance K841478 for RIANEN CYCLIC-AMP RADIOIMMUNOASSAY, Substantially Equivalent on 1984-06-14. Applicant: New England Nuclear. Device class: 2.

Clearance details

Applicant: New England Nuclear
Product code: Code CHO
Device class: Class 2
Regulation: 21 CFR 862.1230
Advisory panel: Clinical Chemistry
Date received: 1984-04-09
Decision date: 1984-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHO

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K860253 — AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)1986-03-14
K844135 — PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU1985-03-05
K823504 — CYCLIC ADENOSINE MONOPHOSHATE BY RADIO1983-01-28
K811746 — KING DIAGNOSTICS CHOLESTEROL-FE TEST1981-07-10
K811273 — CYCLIC AMP RADIOIMMUNOASSAY KIT [125I]1981-05-27

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K840301 — RIANEN ESTRIOL RADIOIMMUNOASSAY KIT1984-03-30
K834038 — RIANEN FOLLICLE STIMULATING HORMONE1984-01-30
K833376 — RIANEN LUTEINIZING HORMONE RIA KIT1983-12-20
K831345 — RIANEN PROLACTIN 125I KIT1983-06-08
K801245 — ATOMLIGHT (LIQUID SCINTILLATION SOLUTION1980-06-20

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