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Venom Tiem Reagent

by Medical Diagnostic Technologies, Inc.

510(k) K955115

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 NumberK955115 Date3 Apr 1996ClearedStatusActive

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  • Withdrawn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
JCO
Device Class
Class II
Regulation
21 CFR Part 864.8100
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.

The Venom Tiem Reagent is a Bothrops Atrox Reagent used in hematology applications. It functions as a diagnostic reagent for laboratory testing procedures.

This device is classified as a Class II medical device under regulation number 864.8100. It has received FDA 510(k) clearance under the identifier K955115.

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