RIANEN PROLACTIN 125I KIT— 510(k) K831345

Substantially Equivalent

New England Nuclear

FDA 510(k) clearance K831345 for RIANEN PROLACTIN 125I KIT, Substantially Equivalent on 1983-06-08. Applicant: New England Nuclear. Device class: 1.

Clearance details

Applicant: New England Nuclear
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1983-04-25
Decision date: 1983-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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More clearances from New England Nuclear

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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
K801245 — ATOMLIGHT (LIQUID SCINTILLATION SOLUTION1980-06-20

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