Cleared Traditional

CORNING MAGIC MAB HCG RADIOIMMUNOASSAY

K854024 · Corning Medical & Scientific · Chemistry
Nov 1985
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K854024 is an FDA 510(k) clearance for the CORNING MAGIC MAB HCG RADIOIMMUNOASSAY, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Corning Medical & Scientific (Medfield, US). The FDA issued a Cleared decision on November 26, 1985, 57 days after receiving the submission on September 30, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K854024 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1985
Decision Date November 26, 1985
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHI — Visual, Pregnancy Hcg, Prescription Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

Similar Devices — JHI Visual, Pregnancy Hcg, Prescription Use

All 374
Innovita HCG Pregnancy Rapid Combo Test
K241919 · Innovita (Tangshan) Biological Technology Co., Ltd. · Aug 2024
Alltest Pregnancy Rapid Combo Test Cassette
K203272 · Hangzhou AllTest Biotech Co., Ltd. · Jan 2022
Atellica IM Total hCG (ThCG)
K172322 · Siemens Healthcare Diagnostics, Inc. · Mar 2018
TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
K172257 · True Diagnostics, Inc. · Dec 2017
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
K152768 · Assure Tech. Co., Ltd. · Feb 2016
WUNDER PREGNANCY TEST
K130456 · James Nguyen · Apr 2014