Model 5500 Ceas
FDA 510(k) K934977 · Esa, Inc.
510(k) numberK934977
Submission
- Device name
- Model 5500 Ceas
- Applicant
- Esa, Inc.
Bedford, MA, US - Received
- October 19, 1993
- Decision date
- January 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| 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 |
|---|---|---|
| K032199 | Esa Plasma Free Metanephrine Analysis KitCHQ · Traditional | 01/30/2004SE |
| K971640 | Leadcare Blood Lead Testing SystemDOF · Traditional | 09/09/1997SE |
| K963938 | Model 5500 CeasCHQ · Traditional | 12/26/1996SE |
| K931148 | Model 5500 Coulochem Electrode Array SystemCHQ · Traditional | 06/09/1993SE |
| K903231 | Coulochem IILEQ · Traditional | 09/27/1990SE |
| K864729 | Neurochemical AnalyzerLEQ · Traditional | 04/13/1987SE |
Questions and answers
When was Model 5500 Ceas cleared by the FDA?
Model 5500 Ceas (K934977) received a 510(k) decision of Substantially Equivalent on January 11, 1994, 84 days after the submission was received.
What is the product code of K934977?
The FDA product code is CDF – Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin, a Class I (low risk) device regulated under 21 CFR 862.1795.