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Control Serums For Nontreponemal Test

by Hillside Acres, Inc.

510(k) K810119

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 NumberK810119 Date9 Feb 1981ClearedStatusActive

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  • Withdrawn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
GMP
Device Class
Class II
Regulation
21 CFR Part 866.3820
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Control Serums for Nontreponemal Test are standardized sera used in serological tests to identify reagin. These reagents serve as a control to which test results are compared during the detection of antibody-like agents produced from the reaction of treponema.

This device is identified under FDA 510(k) clearance K810119 and is classified as a class 2 medical device. It is manufactured by Hillside Acres, Inc. and is regulated under 21 CFR 866.3820.

Questions

AI-generated answers, 22 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 primary purpose of the Control Serums for Nontreponemal Test?

    These standardized sera are used as a control reagent in serological testing. They provide a baseline to which test results are compared when detecting antibody-like agents produced during the reaction of treponema.

  • How is this device regulated?

    This device is classified as a class 2 medical device under 21 CFR 866.3820. It has received FDA 510(k) clearance under the number K810119, indicating it has been found substantially equivalent to legally marketed predicate devices.

  • Who is the manufacturer of these control serums?

    The Control Serums for Nontreponemal Test are manufactured by Hillside Acres, Inc., located in Mchenry, Illinois.