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Donnect. Diag. Total Bilirubin Reagents

by Connecticut Diagnostics, Ltd.

510(k) K792338

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 NumberK792338 Date6 Dec 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  • Withdrawn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
CIG
Device Class
Class II
Regulation
21 CFR Part 862.1110
Advisory Committee
Clinical Chemistry
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.

The Donnect. Diag. Total Bilirubin Reagents are diagnostic reagents used for diazo colorimetry to measure bilirubin levels. This device is classified under clinical chemistry for the quantitative determination of bilirubin in human serum or plasma.

This device has received FDA 510(k) clearance under the regulation number 862.1110. It is intended for professional use in clinical laboratory settings.

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