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Be-Sure

by Precision Products Corp.

510(k) K791706

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK791706 Date17 Oct 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
JHJ
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Be-Sure is an agglutination method device used for the detection of human chorionic gonadotropin. It is classified as a clinical chemistry device.

This device is identified by K791706 and received FDA 510(k) clearance on October 17, 1979. It is manufactured by Precision Products Corp.

Questions

AI-generated answers, 6 Oct 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 primary function of the Be-Sure device?

    The Be-Sure is an agglutination method device specifically designed for the detection of human chorionic gonadotropin in a clinical setting.

  • How is the Be-Sure device classified for clinical use?

    The Be-Sure device is classified as a clinical chemistry device under regulation number 862.1155 and is categorized as a Class 2 medical device.

  • What is the regulatory status of the Be-Sure device?

    The Be-Sure device, identified by K791706, received FDA 510(k) clearance on October 17, 1979, following a determination of substantial equivalence.