FDA product code DAA: Igg, Peroxidase, Antigen, Antiserum, Control
DAA is the FDA product code for igg, peroxidase, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Pathology panel. FDA has cleared 5 510(k) submissions under DAA, from 3 different applicants. The average 510(k) review took 55 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Igg, Peroxidase, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DAA clearance
Top DAA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clinical Sciences, Inc. | 3 | 1983-09-12 |
| Breit Laboratories, Inc. | 1 | 1983-07-18 |
| Diagnostic Reagent Tech. | 1 | 1983-06-02 |
Most recent DAA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832675 | Clinical Sciences, Inc. | ANA MICROZYME TEST SYS #1610 | 1983-09-12 | 34 |
| K831927 | Breit Laboratories, Inc. | ANTINUCLEAR ANTIBODY TEST KIT | 1983-07-18 | 33 |
| K830005 | Diagnostic Reagent Tech. | IP SPECIFIC G | 1983-06-02 | 150 |
| K822911 | Clinical Sciences, Inc. | ANAZYME ANA PEROXIDASE TEST SYSTEM | 1982-10-22 | 21 |
| K791749 | Clinical Sciences, Inc. | INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL | 1979-10-17 | 37 |
Recalls for DAA devices
openFDA lists no recalls for product code DAA.
Frequently asked questions
What is FDA product code DAA?
DAA is the FDA product code for igg, peroxidase, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Pathology panel.
What device class is DAA?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code DAA?
Across 5 cleared submissions the average was 55 days from receipt to decision (median 34).
Which companies have the most DAA clearances?
Clinical Sciences, Inc. (3); Breit Laboratories, Inc. (1); Diagnostic Reagent Tech. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DAA
- Run a recall and safety report across every DAA manufacturer
- Watch product code DAA 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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