Skip to content

Corning Transphor

by Corning Medical & Scientific

510(k) K800544

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 NumberK800544 Date20 Mar 1980ClearedStatusActive

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  • Withdrawn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
JHX
Device Class
Class II
Regulation
21 CFR Part 862.1215
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Corning Transphor is a fluorometric method device for clinical chemistry applications, designed to measure creatine phosphokinase (CPK) and isoenzymes. It employs fluorometric analysis to quantify biochemical markers, supporting diagnostic evaluations in clinical settings. The device falls under the regulatory classification of a Class II medical device, as defined by FDA regulation 862.1215.

This device is intended for use in laboratory settings and is supplied as a reusable instrument. It requires no specific sterility standards beyond standard laboratory hygiene protocols. The Transphor operates under traditional regulatory clearance (510(k) K800544) and was granted FDA 510(k) clearance in 1980 under the Clinical Chemistry advisory committee. No MRI safety or size-specific storage instructions are noted in the regulatory data.

Other devices from Corning Medical & Scientific

See all devices from Corning Medical & Scientific →

Questions

AI-generated answers, 20 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 specific biochemical markers does the Corning Transphor measure, and how does it perform these measurements?

    The Corning Transphor measures creatine phosphokinase (CPK) and its isoenzymes using a fluorometric method. This technique quantifies biochemical markers by detecting fluorescence emitted during enzymatic reactions, enabling precise diagnostic evaluations in clinical chemistry laboratories.

  • Is the Corning Transphor designed for single-use or reusable applications, and what maintenance considerations should be noted?

    The Corning Transphor is supplied as a reusable instrument, intended for use in laboratory settings. While it does not require specialized sterility beyond standard laboratory hygiene protocols, routine maintenance and cleaning per manufacturer guidelines are essential to ensure accurate and reliable performance over time.

  • What regulatory pathway was followed for the Corning Transphor’s FDA clearance, and which advisory committee was involved?

    The Corning Transphor received FDA clearance through a traditional 510(k) pathway (K800544) under the Clinical Chemistry advisory committee (CH). The device was determined to be substantially equivalent to a predicate and was cleared in 1980, adhering to FDA regulation 862.1215 for Class II medical devices.

  • Are there any special storage instructions for the Corning Transphor, particularly regarding environmental conditions or handling?

    The regulatory data does not specify any unique storage instructions beyond standard laboratory conditions. Since it is a reusable instrument, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve functionality and accuracy.