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Biogenics Bioquad 4-WELL IVF Culture Dish

by Biogenics, Inc.

510(k) K081896

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 NumberK081896 Date20 Aug 2008ClearedStatusActive

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  • Withdrawn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
MQK
Device Class
Class II
Regulation
21 CFR Part 884.6160
Advisory Committee
Obstetrics/Gynecology
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 Biogenics Bioquad 4-Well IVF Culture Dish is a labware device used in assisted reproduction. It provides a controlled environment for the preparation, storage, manipulation, or transfer of human gametes and embryos during IVF or related cell culture procedures.

It is a sterile, single-use plasticware device supplied in a non-pyrogenic, embryotoxically tested format. The device is intended for use in clinical or laboratory settings handling human reproductive cells and is authorized under FDA 510(k) clearance K081896.

Questions

AI-generated answers, 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.

  • What is the Biogenics Bioquad 4-Well IVF Culture Dish used for?

    The Biogenics Bioquad 4-Well IVF Culture Dish is a labware device designed for use in assisted reproduction procedures. It provides a controlled environment for the preparation, storage, manipulation, or transfer of human gametes and embryos during IVF or related cell culture procedures in clinical or laboratory settings.

  • Is the Biogenics Bioquad 4-Well IVF Culture Dish reusable or single-use?

    The Biogenics Bioquad 4-Well IVF Culture Dish is a single-use plasticware device. It is supplied in a sterile, non-pyrogenic, embryotoxically tested format and is not intended for reuse to maintain sterility and prevent contamination risks in reproductive procedures.

  • What regulatory authorization does the Biogenics Bioquad 4-Well IVF Culture Dish have?

    The Biogenics Bioquad 4-Well IVF Culture Dish is authorized under FDA 510(k) clearance K081896. It has been determined to be substantially equivalent to existing devices for use in clinical or laboratory settings handling human reproductive cells.

  • How is the Biogenics Bioquad 4-Well IVF Culture Dish supplied?

    The device is supplied as sterile, single-use plasticware in a non-pyrogenic, embryotoxically tested format. This ensures the device meets the necessary safety standards for handling human gametes and embryos during IVF procedures.