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SF-CHECK

by Streck Laboratories, Inc.

510(k) K952245

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 NumberK952245 Date1 Sep 1995ClearedStatusActive

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  • Withdrawn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
JPK
Device Class
Class II
Regulation
21 CFR Part 864.8625
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

SF-CHECK is a hematology quality control mixture. It is a device used for quality control in hematology testing.

SF-CHECK is supplied by Streck Laboratories, Inc. It is a Class II device with product code JPK and regulation number 864.8625, cleared via FDA 510(k) K952245 on September 1, 1995.

Other devices from Streck Laboratories, Inc.

See all devices from Streck Laboratories, Inc. →

Questions

AI-generated answers, 6 Oct 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 SF-CHECK used for?

    SF-CHECK is a hematology quality control mixture used for quality control in hematology testing, as stated in the device description. It is designed to verify the accuracy and precision of hematology analyzers by providing a known reference sample for routine testing procedures.

  • How is SF-CHECK supplied and what is its sterility status?

    SF-CHECK is supplied by Streck Laboratories, Inc. The device data does not specify whether it is sterile or non-sterile, nor does it indicate single-use or reusable status; therefore, sterility and reuse characteristics cannot be confirmed from the provided information.

  • What regulatory pathway was used for SF-CHECK?

    SF-CHECK was cleared via the FDA 510(k) pathway, as indicated by the authorization type FDA_510K and the specific k-number K952245, with clearance granted on September 1, 1995. This means it was found substantially equivalent to a legally marketed predicate device.