FOLLICLE STIMULATING HORMONE (FSH) KIT— 510(k) K792063

Name: FDA 510(k) clearance K792063
Creator: U.S. Food and Drug Administration
Published: 1979-11-20

Substantially Equivalent

Cis Radiopharmaceuticals, Inc.

FDA 510(k) clearance K792063 for FOLLICLE STIMULATING HORMONE (FSH) KIT, Substantially Equivalent on 1979-11-20. Applicant: Cis Radiopharmaceuticals, Inc.. Device class: 1.

Clearance details

Applicant: Cis Radiopharmaceuticals, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1979-10-15
Decision date: 1979-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGJ

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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 Cis Radiopharmaceuticals, Inc.

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K792000 — LUTEINIZING HORMONE (LH) RIA1979-10-30
K791051 — PROGESTERONE RADIOIMMUNOASSAY KIT1979-07-24
K790003 — RIA KIT, PROLACTIN1979-03-12

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