RIANEN ESTRIOL RIA KIT— 510(k) K772323

Substantially Equivalent

New England Nuclear

FDA 510(k) clearance K772323 for RIANEN ESTRIOL RIA KIT, Substantially Equivalent on 1978-01-05. Applicant: New England Nuclear. Device class: 1.

Clearance details

Applicant: New England Nuclear
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1977-12-19
Decision date: 1978-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K834038 — RIANEN FOLLICLE STIMULATING HORMONE1984-01-30
K833376 — RIANEN LUTEINIZING HORMONE RIA KIT1983-12-20
K831345 — RIANEN PROLACTIN 125I KIT1983-06-08

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