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Dia Strips System, Modified

by Symcon Intl., Inc.

510(k) K921495

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK921495 Date21 Jul 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JIO
Device Class
Class II
Regulation
21 CFR Part 864.6550
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Dia Strips System, Modified is an occult blood test device used to detect occult blood in urine or feces. It is classified as a hematology device under product code JIO and regulation number 864.6550.

The device received FDA 510(k) clearance (K921495) on July 21, 1992, and is manufactured by Symcon Intl., Inc. It is a class II medical device with a traditional clearance pathway and was found substantially equivalent to a predicate device.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Dia Strips System, Modified used for?

    The Dia Strips System, Modified is an occult blood test device designed to detect occult blood in urine or feces samples, aiding in the identification of gastrointestinal bleeding or other conditions where blood is not visibly present.

  • How is the Dia Strips System, Modified supplied and is it sterile or single-use?

    The device data does not specify whether the Dia Strips System, Modified is supplied sterile, single-use, or reusable; therefore, no conclusion can be drawn about its sterility, usage format, or packaging from the provided information.

  • What regulatory pathway was used for the Dia Strips System, Modified and when was it cleared?

    The Dia Strips System, Modified received FDA 510(k) clearance through a traditional pathway on July 21, 1992, under submission number K921495, and was determined to be substantially equivalent to a predicate device.