FDA product code DBT: Factor Xiii A, S, Antigen, Antiserum, Control
DBT is the FDA product code for factor xiii a, s, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5330 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under DBT. The average 510(k) review took 98 days (median 98).
Classification
| Field | Value |
|---|---|
| Device name | Factor Xiii A, S, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5330 |
| Review panel | HE — Hematology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DBT clearance
Top DBT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intermedics, Inc. | 1 | 1987-09-15 |
Most recent DBT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872230 | Intermedics, Inc. | MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE | 1987-09-15 | 98 |
Recalls for DBT devices
openFDA lists no recalls for product code DBT.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J7180 — Injection, factor xiii (antihemophilic factor, human), 1 i.u.
- J7181 — Injection, factor xiii a-subunit, (recombinant), per iu
Frequently asked questions
What is FDA product code DBT?
DBT is the FDA product code for factor xiii a, s, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5330 and reviewed by the Hematology panel.
What device class is DBT?
Class I, regulation 21 CFR 866.5330. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DBT?
Across 1 cleared submissions the average was 98 days from receipt to decision (median 98).
Which companies have the most DBT clearances?
Intermedics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DBT
- Run a recall and safety report across every DBT manufacturer
- Watch product code DBT 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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