FDA product code DHL: Protein, Complement, Antigen, Antiserum, Control
DHL is the FDA product code for protein, complement, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.4100 and reviewed by the Immunology panel. FDA has cleared 4 510(k) submissions under DHL, from 4 different applicants. The average 510(k) review took 31 days (median 29).
Classification
| Field | Value |
|---|---|
| Device name | Protein, Complement, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.4100 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Top DHL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diamedix Corp. | 1 | 1987-03-13 |
| Kallestad Laboratories, Inc. | 1 | 1981-06-24 |
| Scripps-Miles, Inc. | 1 | 1981-06-16 |
| Cedarlake Labs , Ltd. | 1 | 1977-06-03 |
Most recent DHL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870351 | Diamedix Corp. | EZ COMPLEMENT REAGENTS, 78N2212 | 1987-03-13 | 43 |
| K811445 | Kallestad Laboratories, Inc. | KALLESTAD R QUANTIPLATE ALT. PATHWAY T. | 1981-06-24 | 33 |
| K811433 | Scripps-Miles, Inc. | SCRIPPSERA COMPLEMENT CONTROL SERA | 1981-06-16 | 25 |
| K770866 | Cedarlake Labs , Ltd. | RABBIT COMPLEMENT | 1977-06-03 | 23 |
Recalls for DHL devices
openFDA lists no recalls for product code DHL.
Frequently asked questions
What is FDA product code DHL?
DHL is the FDA product code for protein, complement, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.4100 and reviewed by the Immunology panel.
What device class is DHL?
Class I, regulation 21 CFR 866.4100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DHL?
Across 4 cleared submissions the average was 31 days from receipt to decision (median 29).
Which companies have the most DHL clearances?
Diamedix Corp. (1); Kallestad Laboratories, Inc. (1); Scripps-Miles, Inc. (1); Cedarlake Labs , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DHL
- Run a recall and safety report across every DHL manufacturer
- Watch product code DHL 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.