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Electric Self Sterilization Inocul. Loop

by Techhnilab Instruments, Inc.

510(k) K813523

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 NumberK813523 Date31 Dec 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  • Withdrawn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
LTB
Device Class
Class II
Regulation
21 CFR Part 862.1235
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Electric Self Sterilization Inoculation Loop is a laboratory device designed for the transfer and inoculation of microbial cultures. It utilizes an electric heating mechanism to achieve self-sterilization, facilitating the maintenance of aseptic conditions during microbiological procedures.

This device is identified under FDA product code LTB and is subject to traditional 510(k) clearance. It is manufactured by Techhnilab Instruments, Inc. and is classified as a Class 2 medical device under regulation number 862.1235.

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