FDA product code LHZ: Viscometer, Mucus, Cervical

LHZ is the FDA product code for viscometer, mucus, cervical. It is a Class I device, regulated under 21 CFR 884.1040 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under LHZ. The average 510(k) review took 786 days (median 786).

Classification

Compare with all 510(k) review times · Search every LHZ clearance

Top LHZ applicants

Most recent LHZ clearances

Recalls for LHZ devices

openFDA lists no recalls for product code LHZ.

Frequently asked questions

What is FDA product code LHZ?

LHZ is the FDA product code for viscometer, mucus, cervical. It is a Class I device, regulated under 21 CFR 884.1040 and reviewed by the Obstetrics and Gynecology panel.

What device class is LHZ?

Class I, regulation 21 CFR 884.1040. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code LHZ?

Across 1 cleared submissions the average was 786 days from receipt to decision (median 786).

Which companies have the most LHZ clearances?

Harold J. Kosasky, M.D. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code LHZ
• Run a recall and safety report across every LHZ manufacturer
• Watch product code LHZ for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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