Product code CDF
- Device name
- Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1795
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K953077 | PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM | Beckman Instruments, Inc. | 1996-01-05 |
| K934977 | MODEL 5500 CEAS | Esa, Inc. | 1994-01-11 |
| K895288 | HVA EIA KIT YAMASA | Yamasa Shoy Co., Ltd. | 1989-10-31 |
| K895287 | VMA EIA KIT YAMASA | Yamasa Shoy Co., Ltd. | 1989-10-30 |
| K873372 | HVA & HOMOVANILLIC ACID BY HPLC METHOD | Bio-Rad | 1987-12-22 |
| K861962 | VANILMANDELIC ACID (VMA) REAGENT SET | Sterling Diagnostics, Inc. | 1986-07-07 |
| K861010 | VMA BY HPLC TEST (VANILMANDELIC ACID) | Bio-Rad | 1986-05-01 |
| K853041 | TRIGLYCERIDES LCK 124 | German American Chamber of Commerce, Inc. | 1985-08-12 |
| K843379 | VMA ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-28 |
| K810992 | HELENA VMA-SMC COLUMN METHOD | Helena Laboratories | 1981-04-29 |
| K791837 | VMA BY COLUMN TEST | Bio-Rad | 1979-10-30 |
| K772151 | URINARY VMA - SCREEN TEST KIT | Eppendorf-Brinkmann, Inc. | 1977-11-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04250317557612 | Analytes Mix | Chromsystems Instruments + Chemicals GmbH | 2025-06-20 |
| 04250317557476 | Basic Kit | Chromsystems Instruments + Chemicals GmbH | 2025-06-20 |
| 04250317557483 | Reagent Kit | Chromsystems Instruments + Chemicals GmbH | 2025-06-20 |
| 04250317557605 | Analytes Mix | Chromsystems Instruments + Chemicals GmbH | 2025-06-20 |
| 04250317500281 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317500328 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317500335 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317500403 | Accessorie | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317500519 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317500526 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317500533 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317500564 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317517555 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317500557 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317500397 | Accessorie | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317500496 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317500465 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317500069 | Reagent Kit | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317536662 | Reagent Kit | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317537294 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317537300 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317537393 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317500311 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317500274 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317500250 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317500144 | Reagent Kit | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317500120 | Reagent Kit | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317500106 | Reagent Kit | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317543240 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317546234 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |