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 862.1795](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1795) → CDF — Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin

# CDF · Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin

_Clinical Chemistry · 21 CFR 862.1795 · Class 1_

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

## Overview

- **Product Code:** CDF
- **Device Name:** Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
- **Regulation:** [21 CFR 862.1795](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1795)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A vanilmandelic acid test system is a device intended to measure vanilmandelic acid in urine. Measurements of vanilmandelic acid obtained by this device are used in the diagnosis and treatment of neuroblastoma, pheochromocytoma, and certain hypertensive conditions.

## 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 (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K953077](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K953077.md) | PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM | Beckman Instruments, Inc. | Jan 5, 1996 | SESE |
| [K934977](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K934977.md) | MODEL 5500 CEAS | Esa, Inc. | Jan 11, 1994 | SESE |
| [K895288](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K895288.md) | HVA EIA KIT YAMASA | Yamasa Shoy Co., Ltd. | Oct 31, 1989 | SESE |
| [K895287](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K895287.md) | VMA EIA KIT YAMASA | Yamasa Shoy Co., Ltd. | Oct 30, 1989 | SESE |
| [K873372](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K873372.md) | HVA & HOMOVANILLIC ACID BY HPLC METHOD | Bio-Rad | Dec 22, 1987 | SESE |
| [K861962](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K861962.md) | VANILMANDELIC ACID (VMA) REAGENT SET | Sterling Diagnostics, Inc. | Jul 7, 1986 | SESE |
| [K861010](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K861010.md) | VMA BY HPLC TEST (VANILMANDELIC ACID) | Bio-Rad | May 1, 1986 | SESE |
| [K853041](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K853041.md) | TRIGLYCERIDES LCK 124 | German American Chamber of Commerce, Inc. | Aug 12, 1985 | SESE |
| [K843379](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K843379.md) | VMA ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | Sep 28, 1984 | SESE |
| [K810992](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K810992.md) | HELENA VMA-SMC COLUMN METHOD | Helena Laboratories | Apr 29, 1981 | SESE |
| [K791837](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K791837.md) | VMA BY COLUMN TEST | Bio-Rad | Oct 30, 1979 | SESE |
| [K772151](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K772151.md) | URINARY VMA - SCREEN TEST KIT | Eppendorf-Brinkmann, Inc. | Nov 30, 1977 | SESE |

## Top Applicants

- Bio-Rad — 3 clearances
- Yamasa Shoy Co., Ltd. — 2 clearances
- Beckman Instruments, Inc. — 1 clearance
- Diagnostic Chemicals, Ltd. (Usa) — 1 clearance
- Eppendorf-Brinkmann, Inc. — 1 clearance

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

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