Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1430](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1430) → CCY — Zimmerman (Spectrophotometric), 17-Ketosteroids

# CCY · Zimmerman (Spectrophotometric), 17-Ketosteroids

_Clinical Chemistry · 21 CFR 862.1430 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CCY

## Overview

- **Product Code:** CCY
- **Device Name:** Zimmerman (Spectrophotometric), 17-Ketosteroids
- **Regulation:** [21 CFR 862.1430](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1430)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A 17-ketosteroids test system is a device intended to measure 17-ketosteroids in urine. Measurements of 17-ketosteroids are used in the diagnosis and treatment of disorders of the adrenal cortex and gonads and of other endocrine disorders, including hypertension, diabetes, and hypothyroidism.

## 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 § 862.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K782116](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CCY/K782116.md) | KETOSTEROID TEST, HYCEL-17 | Hycel, Inc. | Jan 26, 1979 | SESE |

## Top Applicants

- Hycel, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CCY](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CCY)

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