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Qualitrol Mono Control Serum Set

by Consolidated Technologies, Inc.

510(k) K961550

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 NumberK961550 Date24 Sep 1996ClearedStatusActive

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  • Withdrawn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
KTN
Device Class
Class II
Regulation
21 CFR Part 866.5640
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Qualitrol Mono Control Serum Set is a system test for infectious mononucleosis. It is classified as a Class II medical device under regulation number 866.5640.

The device received traditional 510(k) clearance (K961550) on September 24, 1996, and is substantially equivalent to a predicate device. It is manufactured by Consolidated Technologies, Inc. in Austin, Texas, and is used in immunology testing.

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