Name: FDA 510(k) clearance K823753
Creator: U.S. Food and Drug Administration
Published: 1983-01-24

Clearance details

Applicant: Armkel, LLC
Product code: Code JHI
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1982-12-14
Decision date: 1983-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip2016-02-24

More clearances from Armkel, LLC

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K040866 — FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST2004-10-19
K030258 — FIRST RESPONSE PREGNANCY TEST2003-02-25
K023405 — TROJAN MINT TINGLE BRAND LATEX CONDOMS2002-12-16
K013433 — TROJAN PASSION BERRY GEL2002-03-05
K013614 — TROJAN CRYSTAL CLEAR LIQUID2002-02-01

Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →