CDF · Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
Clinical Chemistry · 21 CFR 862.1795 · Class 1
Overview
| Product Code | CDF |
|---|---|
| Device Name | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin |
| Regulation | 21 CFR 862.1795 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Cleared Devices (12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K953077 | PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM | Beckman Instruments, Inc. | Jan 5, 1996 | SESE |
| K934977 | MODEL 5500 CEAS | Esa, Inc. | Jan 11, 1994 | SESE |
| K895288 | HVA EIA KIT YAMASA | Yamasa Shoy Co., Ltd. | Oct 31, 1989 | SESE |
| K895287 | VMA EIA KIT YAMASA | Yamasa Shoy Co., Ltd. | Oct 30, 1989 | SESE |
| K873372 | HVA & HOMOVANILLIC ACID BY HPLC METHOD | Bio-Rad | Dec 22, 1987 | SESE |
| K861962 | VANILMANDELIC ACID (VMA) REAGENT SET | Sterling Diagnostics, Inc. | Jul 7, 1986 | SESE |
| K861010 | VMA BY HPLC TEST (VANILMANDELIC ACID) | Bio-Rad | May 1, 1986 | SESE |
| K853041 | TRIGLYCERIDES LCK 124 | German American Chamber of Commerce, Inc. | Aug 12, 1985 | SESE |
| K843379 | VMA ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | Sep 28, 1984 | SESE |
| K810992 | HELENA VMA-SMC COLUMN METHOD | Helena Laboratories | Apr 29, 1981 | SESE |
| K791837 | VMA BY COLUMN TEST | Bio-Rad | Oct 30, 1979 | SESE |
| K772151 | URINARY VMA - SCREEN TEST KIT | Eppendorf-Brinkmann, Inc. | Nov 30, 1977 | SESE |
Top Applicants
- Bio-Rad — 3 clearances
- Yamasa Shoy Co., Ltd. — 2 clearances
- Sterling Diagnostics, Inc. — 1 clearance
- Helena Laboratories — 1 clearance
- German American Chamber of Commerce, Inc. — 1 clearance
