IMMO PHASE FSH RADIOIMMUNOASSAY— 510(k) K822227

Name: FDA 510(k) clearance K822227
Creator: U.S. Food and Drug Administration
Published: 1982-08-16

Substantially Equivalent

Corning Medical & Scientific

FDA 510(k) clearance K822227 for IMMO PHASE FSH RADIOIMMUNOASSAY, Substantially Equivalent on 1982-08-16. Applicant: Corning Medical & Scientific. Device class: 1.

Clearance details

Applicant: Corning Medical & Scientific
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1982-07-27
Decision date: 1982-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGJ

view all

K052662 — ONE STEP FSH MENOPAUSAL TEST2005-11-30
K043599 — MOMENTS MENOPAUSE CHECK, MODEL 91132005-02-25
K041165 — FSH MENOPAUSE PREDICTOR TEST2004-06-17
K040575 — PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 91122004-05-20
K030058 — EARLYDETECT MENOPAUSE TEST FOR FSH2003-07-30

More clearances from Corning Medical & Scientific

view all

K875122 — DISPOSABLE STERILE SYRINGE FILTERS1988-01-12
K872273 — CORNING EASY WASH ELISA PLATES1987-07-07
K872076 — CORNING DISPOSABLE ROLLER BOTTLES1987-06-15
K863789 — CORNING ELISA PLATES1986-10-03
K854024 — CORNING MAGIC MAB HCG RADIOIMMUNOASSAY1985-11-26

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