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Indicator, Bipolar Temperature

by Micronex, Inc.

510(k) K782043

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 NumberK782043 Date17 Jan 1979ClearedStatusActive

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  • Withdrawn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
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

An indicator, bipolar temperature is a device used to monitor temperature in bipolar applications. It functions as part of a temperature control system that includes a thermistor probe and heaters to provide reliable and accurate temperature regulation in small experimental chambers for studying acutely isolated or cultured cells.

The device is supplied as part of a system and is used in laboratory or research settings. It is not described as sterile, single-use, or reusable in the provided data, and no MRI safety information is specified. The device received FDA 510(k) clearance (K782043) on January 17, 1979, under product code FLL, and is classified as substantially equivalent to a predicate device.

Questions

AI-generated answers, 26 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 INDICATOR, BIPOLAR TEMPERATURE used for?

    The INDICATOR, BIPOLAR TEMPERATURE is used to monitor temperature in bipolar applications as part of a temperature control system that includes a thermistor probe and heaters to provide reliable and accurate temperature regulation in small experimental chambers for studying acutely isolated or cultured cells.

  • Is the INDICATOR, BIPOLAR TEMPERATURE supplied as a standalone device or as part of a system?

    The device is supplied as part of a system and is used in laboratory or research settings, meaning it is not provided as a standalone unit but integrated with other components like a thermistor probe and heaters for temperature control functionality.

  • Is the INDICATOR, BIPOLAR TEMPERATURE described as sterile, single-use, or reusable?

    The device is not described as sterile, single-use, or reusable in the provided data, so no claims can be made about its sterility or reuse status based on the information available.

  • What regulatory pathway was used for the INDICATOR, BIPOLAR TEMPERATURE?

    The device received FDA 510(k) clearance (K782043) on January 17, 1979, under product code FLL, and was determined to be substantially equivalent to a predicate device through the traditional 510(k) pathway.