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Tech Dimple C-Reactive Protein Serum Control

by Simplicity Diagnostics, Inc.

510(k) K922722

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 NumberK922722 Date5 Oct 1992ClearedStatusActive

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  • Withdrawn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
DCK
Device Class
Class II
Regulation
21 CFR Part 866.5270
Advisory Committee
Immunology
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 Tech Dimple C-Reactive Protein Serum Control is a device used in immunology for the control of c-reactive protein serum. It is classified as a device with a product code of DCK. The device is substantially equivalent and has a regulation number of 866.5270.

The device is supplied by Simplicity Diagnostics, Inc. and has been granted FDA 510K clearance with the k number K922722. The device is used in the field of immunology and has a medical specialty description of Immunology. The device has various registration numbers and fei numbers associated with it.

Other devices from Simplicity Diagnostics, Inc.