FDA product code CDF: Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
CDF is the FDA product code for acid, vanilmandelic, diazo, p-nitroaniline/vanillin. It is a Class I device, regulated under 21 CFR 862.1795 and reviewed by the Clinical Chemistry panel. FDA has cleared 12 510(k) submissions under CDF, from 9 different applicants. The average 510(k) review took 62 days (median 47).
Classification
| Field | Value |
|---|---|
| Device name | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin |
| Device class | Class I |
| Regulation | 21 CFR 862.1795 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CDF clearance
Top CDF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 3 | 1987-12-22 |
| Yamasa Shoy Co., Ltd. | 2 | 1989-10-31 |
| Beckman Instruments, Inc. | 1 | 1996-01-05 |
| Esa, Inc. | 1 | 1994-01-11 |
| Sterling Diagnostics, Inc. | 1 | 1986-07-07 |
4 more applicants have CDF clearances. See the full list in Caduvo.
Most recent CDF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K953077 | Beckman Instruments, Inc. | PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM | 1996-01-05 | 189 |
| K934977 | Esa, Inc. | MODEL 5500 CEAS | 1994-01-11 | 84 |
| K895288 | Yamasa Shoy Co., Ltd. | HVA EIA KIT YAMASA | 1989-10-31 | 67 |
| K895287 | Yamasa Shoy Co., Ltd. | VMA EIA KIT YAMASA | 1989-10-30 | 66 |
| K873372 | Bio-Rad | HVA & HOMOVANILLIC ACID BY HPLC METHOD | 1987-12-22 | 120 |
Recalls for CDF devices
openFDA lists no recalls for product code CDF.
Frequently asked questions
What is FDA product code CDF?
CDF is the FDA product code for acid, vanilmandelic, diazo, p-nitroaniline/vanillin. It is a Class I device, regulated under 21 CFR 862.1795 and reviewed by the Clinical Chemistry panel.
What device class is CDF?
Class I, regulation 21 CFR 862.1795. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CDF?
Across 12 cleared submissions the average was 62 days from receipt to decision (median 47).
Which companies have the most CDF clearances?
Bio-Rad (3); Yamasa Shoy Co., Ltd. (2); Beckman Instruments, Inc. (1); Esa, Inc. (1); Sterling Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CDF
- Run a recall and safety report across every CDF manufacturer
- Watch product code CDF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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