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Il Test Protein S

by Instrumentation Laboratory CO

510(k) K930327

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 NumberK930327 Date12 Apr 1993ClearedStatusActive

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  • Withdrawn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)

Full name
Il Test(Tm) Protein S
510(k) Number
FDA product code
GGP
Device class
Class II
Regulation
21 CFR Part 864.7290
Advisory committee
Hematology
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 Il Test Protein S is a qualitative and quantitative factor deficiency test used in hematology. It is designed to assist in the assessment of Protein S levels within a clinical setting.

This device is classified as a Class 2 medical device under regulation number 864.7290. It has received FDA 510(k) clearance under the submission number K930327.

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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 clinical use of the IL Test Protein S?

    This device is designed for use in hematology settings to perform qualitative and quantitative assessments of Protein S levels, assisting clinicians in identifying factor deficiencies.

  • What is the regulatory status of this device?

    The IL Test Protein S is a Class 2 medical device that has received FDA 510(k) clearance under submission number K930327, as it was determined to be substantially equivalent to existing devices.

  • Under which regulation is this test classified?

    This device is classified under regulation number 864.7290, which pertains to devices used for the qualitative and quantitative assessment of factor deficiencies in a clinical laboratory environment.