Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
The Diazo/P-Nitroaniline/Vanillin Vanilmandelic Acid Test is a clinical chemistry device that measures vanilmandelic acid (VMA) levels in urine using diazonium-based colorimetric chemistry, used in the screening and monitoring of catecholamine-secreting tumors such as pheochromocytoma and neuroblastoma. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CDF, regulated under 21 CFR 862.1795, within the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- CDF
- Device Class
- FDA class 1
- Regulation Number
- 862.1795
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K953077 | PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM | Jan 05, 1996 | Substantially Equivalent | Beckman Instruments, Inc. |
| K934977 | MODEL 5500 CEAS | Jan 11, 1994 | Substantially Equivalent | Esa, Inc. |
| K895288 | HVA EIA KIT YAMASA | Oct 31, 1989 | Substantially Equivalent | Yamasa Shoy Co., Ltd. |
| K895287 | VMA EIA KIT YAMASA | Oct 30, 1989 | Substantially Equivalent | Yamasa Shoy Co., Ltd. |
| K873372 | HVA & HOMOVANILLIC ACID BY HPLC METHOD | Dec 22, 1987 | Substantially Equivalent | Bio-Rad |
| K861962 | VANILMANDELIC ACID (VMA) REAGENT SET | Jul 07, 1986 | Substantially Equivalent | Sterling Diagnostics, Inc. |
| K861010 | VMA BY HPLC TEST (VANILMANDELIC ACID) | May 01, 1986 | Substantially Equivalent | Bio-Rad |
| K853041 | TRIGLYCERIDES LCK 124 | Aug 12, 1985 | Substantially Equivalent | German American Chamber of Commerce, Inc. |
| K843379 | VMA ASSAY KIT | Sep 28, 1984 | Substantially Equivalent | Diagnostic Chemicals, Ltd. (Usa) |
| K810992 | HELENA VMA-SMC COLUMN METHOD | Apr 29, 1981 | Substantially Equivalent | Helena Laboratories |
| K791837 | VMA BY COLUMN TEST | Oct 30, 1979 | Substantially Equivalent | Bio-Rad |
| K772151 | URINARY VMA - SCREEN TEST KIT | Nov 30, 1977 | Substantially Equivalent | Eppendorf-Brinkmann, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.