Cleared Traditional

K992695 - INSURE PRO TEST
(FDA 510(k) Clearance)

K992695 · Inbios Intl., Inc. · Chemistry
Oct 1999
Decision
68d
Days
Class 2
Risk

K992695 is an FDA 510(k) clearance for the INSURE PRO TEST, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Inbios Intl., Inc. (Seattle, US). The FDA issued a Cleared decision on October 18, 1999, 68 days after receiving the submission on August 11, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K992695 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1999
Decision Date October 18, 1999
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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