FDA product code DDS: Prealbumin, Fitc, Antigen, Antiserum, Control
DDS is the FDA product code for prealbumin, fitc, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5060 and reviewed by the Immunology panel. FDA has cleared 4 510(k) submissions under DDS, from 3 different applicants. The average 510(k) review took 84 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Prealbumin, Fitc, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5060 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DDS clearance
Top DDS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 2 | 1997-05-09 |
| Hemagen Diagnostics, Inc. | 1 | 1997-08-28 |
| Incstar Corp. | 1 | 1994-01-11 |
Most recent DDS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972812 | Hemagen Diagnostics, Inc. | RAICHEM PREALBUMIN SPIA | 1997-08-28 | 31 |
| K964781 | Beckman Instruments, Inc. | IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT | 1997-05-09 | 163 |
| K934966 | Incstar Corp. | SPQ PAL CONTROL LEVEL II | 1994-01-11 | 88 |
| K854811 | Beckman Instruments, Inc. | ICS PAB PREALBUMIN REAGENT TEST KIT | 1986-01-24 | 52 |
Recalls for DDS devices
openFDA lists no recalls for product code DDS.
Frequently asked questions
What is FDA product code DDS?
DDS is the FDA product code for prealbumin, fitc, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5060 and reviewed by the Immunology panel.
What device class is DDS?
Class I, regulation 21 CFR 866.5060. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DDS?
Across 4 cleared submissions the average was 84 days from receipt to decision (median 70).
Which companies have the most DDS clearances?
Beckman Instruments, Inc. (2); Hemagen Diagnostics, Inc. (1); Incstar Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DDS
- Run a recall and safety report across every DDS manufacturer
- Watch product code DDS 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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