Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart B — Obstetrical and Gynecological Diagnostic Devices](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices) → [21 CFR 884.1040](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1040) → LHZ — Viscometer, Mucus, Cervical

# LHZ · Viscometer, Mucus, Cervical

_Obstetrics/Gynecology · 21 CFR 884.1040 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/LHZ

## Overview

- **Product Code:** LHZ
- **Device Name:** Viscometer, Mucus, Cervical
- **Regulation:** [21 CFR 884.1040](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1040)
- **Device Class:** 1
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## Identification

A viscometer for cervical mucus is a device that is intended to measure the relative viscoelasticity of cervical mucus collected from a female patient. Measurements of relative viscoelasticity are intended for use as an adjunct in the clinical evaluation of a female with chronic infertility, to determine the time of ovulation and the penetrability of cervical mucus to motile sperm.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 884.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K936006](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/LHZ/K936006.md) | SALTIME VISCOMETER | Harold J. Kosasky, M.D. | Feb 9, 1996 | SESE |

## Top Applicants

- Harold J. Kosasky, M.D. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/LHZ](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/LHZ)

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