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Fun-UV System Pack Test

by Boehringer Mannheim Corp.

510(k) K812290

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 NumberK812290 Date31 Aug 1981ClearedStatusActive

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  • Withdrawn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
CDQ
Device Class
Class II
Regulation
21 CFR Part 862.1770
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Fun-UV System Pack Test is a diagnostic in vitro device used for the quantitative determination of urea nitrogen in serum or plasma. It employs urease and glutamic dehydrogenase enzymes to catalyze reactions measurable via ultraviolet spectrophotometry, enabling accurate blood urea nitrogen (BUN) analysis in clinical chemistry applications.

This device is intended for single-use in laboratory settings and requires no sterilization beyond manufacturer-provided packaging. It is classified as a Class II medical device under FDA regulation 862.1770 and has received FDA 510(k) clearance (K812290) as substantially equivalent to a predicate device. The system is designed for use with the Fun-UV System, adhering to clinical chemistry standards for blood chemistry analysis.

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