FDA product code DLR: Hemagglutination Inhibition, Morphine
DLR is the FDA product code for hemagglutination inhibition, morphine. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under DLR, from 2 different applicants. The average 510(k) review took 48 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Hemagglutination Inhibition, Morphine |
| Device class | Class II |
| Regulation | 21 CFR 862.3640 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DLR clearance
Top DLR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Technam, Inc. | 1 | 1979-10-17 |
| J.T. Baker Chemical Co. | 1 | 1976-07-20 |
Most recent DLR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K791551 | Technam, Inc. | HI-M-TEST MORPHINE | 1979-10-17 | 64 |
| K760074 | J.T. Baker Chemical Co. | KIT, MORPHINE (TOXI-PAK IMMUNO HI) | 1976-07-20 | 32 |
Recalls for DLR devices
openFDA lists no recalls for product code DLR.
Frequently asked questions
What is FDA product code DLR?
DLR is the FDA product code for hemagglutination inhibition, morphine. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel.
What device class is DLR?
Class II, regulation 21 CFR 862.3640. Typical premarket route: 510(k).
How long does a 510(k) take for product code DLR?
Across 2 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most DLR clearances?
Technam, Inc. (1); J.T. Baker Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DLR
- Run a recall and safety report across every DLR manufacturer
- Watch product code DLR 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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