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PVP-Polyvinylpyrrolidone Reagent, Model Cat#2210

by Invitrocare Inc

510(k) K001967

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 NumberK001967 Date14 Aug 2000ClearedStatusActive

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  • Withdrawn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
MQL
FDA applicant
Invitrocare, Inc.
Device Class
Class II
Regulation
21 CFR Part 884.6180
Advisory Committee
Obstetrics/Gynecology
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 PVP-Polyvinylpyrrolidone Reagent is a medical device composed of polyvinylpyrrolidone with a molecular weight of 360,000 dissolved in a combined sodium bicarbonate/HEPES buffering system. It is designed for laboratory procedures that do not require a carbon dioxide environment. This reagent is classified under the product code MQL and is intended for use in obstetrics and gynecology applications.

The device is supplied by Invitrocare, Inc. and has received FDA 510(k) clearance with the number K001967. It is a Class II medical device and is not specified as single-use or reusable. The reagent is stored and used according to laboratory protocols, and no specific MRI safety information is provided in the data. The device is authorized for distribution in the United States.

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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 the PVP-Polyvinylpyrrolidone Reagent used for?

    The PVP-Polyvinylpyrrolidone Reagent is designed for laboratory procedures in obstetrics and gynecology that do not require a carbon dioxide environment. It contains polyvinylpyrrolidone with a molecular weight of 360,000 dissolved in a sodium bicarbonate/HEPES buffering system.

  • How is the PVP-Polyvinylpyrrolidone Reagent supplied?

    The reagent is supplied by Invitrocare, Inc. and is classified as a Class II medical device. It is not specified as single-use or reusable, so usage should follow laboratory protocols. The device is authorized for distribution in the United States.

  • What regulatory status does the PVP-Polyvinylpyrrolidone Reagent have?

    The PVP-Polyvinylpyrrolidone Reagent has received FDA 510(k) clearance with the number K001967. It is classified under product code MQL and was determined to be substantially equivalent to predicate devices for obstetrics and gynecology applications.

  • What are the storage requirements for the PVP-Polyvinylpyrrolidone Reagent?

    The reagent should be stored and used according to standard laboratory protocols. No specific storage conditions are provided in the device data beyond following laboratory guidelines for proper handling and preservation of the reagent's integrity.