FDA product code DBE: Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
DBE is the FDA product code for antismooth muscle antibody, indirect immunofluorescent, antigen, control. It is a Class II device, regulated under 21 CFR 866.5120 and reviewed by the Immunology panel. FDA has cleared 6 510(k) submissions under DBE, from 6 different applicants. The average 510(k) review took 26 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5120 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DBE clearance
Top DBE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immuno-Products Industries | 1 | 1981-05-01 |
| Calbiochem-Behring Corp. | 1 | 1980-04-24 |
| Clinical Sciences, Inc. | 1 | 1980-02-21 |
| Medica Corp. | 1 | 1979-04-23 |
| Meloy Laboratories, Inc. | 1 | 1977-08-04 |
1 more applicants have DBE clearances. See the full list in Caduvo.
Most recent DBE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K810983 | Immuno-Products Industries | ANTISMOOTH MUSCLE ANTIBODY TEST SYS | 1981-05-01 | 18 |
| K800820 | Calbiochem-Behring Corp. | AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY | 1980-04-24 | 13 |
| K800228 | Clinical Sciences, Inc. | IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT | 1980-02-21 | 16 |
| K790430 | Medica Corp. | MEDICA II-F-ASMA TEST KIT | 1979-04-23 | 52 |
| K771155 | Meloy Laboratories, Inc. | ANTI-MITOCHONDRIAL | 1977-08-04 | 37 |
Recalls for DBE devices
openFDA lists no recalls for product code DBE.
Frequently asked questions
What is FDA product code DBE?
DBE is the FDA product code for antismooth muscle antibody, indirect immunofluorescent, antigen, control. It is a Class II device, regulated under 21 CFR 866.5120 and reviewed by the Immunology panel.
What device class is DBE?
Class II, regulation 21 CFR 866.5120. Typical premarket route: 510(k).
How long does a 510(k) take for product code DBE?
Across 6 cleared submissions the average was 26 days from receipt to decision (median 18).
Which companies have the most DBE clearances?
Immuno-Products Industries (1); Calbiochem-Behring Corp. (1); Clinical Sciences, Inc. (1); Medica Corp. (1); Meloy Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DBE
- Run a recall and safety report across every DBE manufacturer
- Watch product code DBE 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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