Vma by HPLC Test (Vanilmandelic Acid)
FDA 510(k) K861010 · Bio-Rad
510(k) numberK861010
Submission
- Device name
- Vma by HPLC Test (Vanilmandelic Acid)
- Applicant
- Bio-Rad
Richmond, CA, US - Received
- March 18, 1986
- Decision date
- May 1, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDF – Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1795
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K953077 | Paragon Cze 2000 Clinical Capillary Electrophoresis SystemCDF · Traditional | Beckman Instruments, Inc. | 01/05/1996SE |
| K934977 | Model 5500 CeasCDF · Traditional | Esa, Inc. | 01/11/1994SE |
| K895288 | Hva Eia Kit YamasaCDF · Traditional | Yamasa Shoy Co., Ltd. | 10/31/1989SE |
| K895287 | Vma Eia Kit YamasaCDF · Traditional | Yamasa Shoy Co., Ltd. | 10/30/1989SE |
| K873372 | Hva & Homovanillic Acid by HPLC MethodCDF · Traditional | Bio-Rad | 12/22/1987SE |
| K861962 | Vanilmandelic Acid (Vma) Reagent SetCDF · Traditional | Sterling Diagnostics, Inc. | 07/07/1986SE |
| K853041 | Triglycerides LCK 124CDF · Traditional | German American Chamber of Commerce, Inc. | 08/12/1985SE |
| K843379 | Vma Assay KitCDF · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 09/28/1984SE |
| K810992 | Helena Vma-Smc Column MethodCDF · Traditional | Helena Laboratories | 04/29/1981SE |
| K791837 | Vma by Column TestCDF · Traditional | Bio-Rad | 10/30/1979SE |
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Questions and answers
When was Vma by HPLC Test (Vanilmandelic Acid) cleared by the FDA?
Vma by HPLC Test (Vanilmandelic Acid) (K861010) received a 510(k) decision of Substantially Equivalent on May 1, 1986, 44 days after the submission was received.
What is the product code of K861010?
The FDA product code is CDF – Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin, a Class I (low risk) device regulated under 21 CFR 862.1795.