ONE STEP FSH MENOPAUSAL TEST— 510(k) K052662

Name: FDA 510(k) clearance K052662
Creator: U.S. Food and Drug Administration
Published: 2005-11-30

Substantially Equivalent

Ind Diagnostic, Inc.

FDA 510(k) clearance K052662 for ONE STEP FSH MENOPAUSAL TEST, Substantially Equivalent on 2005-11-30. Applicant: Ind Diagnostic, Inc.. Device class: 1.

Clearance details

Applicant: Ind Diagnostic, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 2005-09-27
Decision date: 2005-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delta, B.C., CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGJ

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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
K002450 — GENUA MENOPAUSE MONITOR TEST KIT2001-01-12

More clearances from Ind Diagnostic, Inc.

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K103037 — IND URINARY TRACT INFECTION (UTI) TEST STRIPS2012-04-17
K100031 — IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-102010-07-19
K063390 — URINE CHEMISTRY ANALYZER UR-502007-03-01
K060810 — ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC2006-08-07
K052694 — ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.2005-12-16

Recalls naming K052662

K-number listed on FDA's recall record

Z-0060-2024 — DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07Class II·Ongoing·Universal Meditech Inc.·20230522

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052662.

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