Vanilmandelic Acid (Vma) Reagent Set
FDA 510(k) K861962 · Sterling Diagnostics, Inc.
510(k) numberK861962
Submission
- Device name
- Vanilmandelic Acid (Vma) Reagent Set
- Applicant
- Sterling Diagnostics, Inc.
Sterling Heights, MI, US - Received
- May 20, 1986
- Decision date
- July 7, 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 |
| K861010 | Vma by HPLC Test (Vanilmandelic Acid)CDF · Traditional | Bio-Rad | 05/01/1986SE |
| 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 |
More from Bio-Rad
| 510(k) | Device | Decision |
|---|---|---|
| K921412 | Microprotein Reagent SetCEK · Traditional | 01/21/1993SE |
| K914609 | Triglycerides Reagent SetCDT · Traditional | 11/07/1991SE |
| K914039 | Sodium Reagent SetCEI · Traditional | 10/31/1991SE |
| K914040 | Phospholipid Reagent SetJNT · Traditional | 10/30/1991SE |
| K862255 | Lactate Dehydrogenase (LDH) Reagent Set (UV Rate)CFJ · Traditional | 07/29/1986SE |
| K862256 | Alkaline Phosphatase (PNPP Rate) Reagent SetCJE · Traditional | 07/01/1986SE |
| K862210 | Urea Nitrogen (GLDH) Reagent Set (UV)CDQ · Traditional | 07/01/1986SE |
| K862209 | Alt (SGPT) Reagent Set (UV Rate)CKA · Traditional | 06/25/1986SE |
| K861855 | Hydroxybutyrate Dehydrogenase (HBD) Reagent SetJKF · Traditional | 06/16/1986SE |
| K861713 | Serum Potassium Reagent SetCEJ · Traditional | 05/23/1986SE |
Questions and answers
When was Vanilmandelic Acid (Vma) Reagent Set cleared by the FDA?
Vanilmandelic Acid (Vma) Reagent Set (K861962) received a 510(k) decision of Substantially Equivalent on July 7, 1986, 48 days after the submission was received.
What is the product code of K861962?
The FDA product code is CDF – Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin, a Class I (low risk) device regulated under 21 CFR 862.1795.