FDA product code LHW: Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
LHW is the FDA product code for erythrocyte suspension, multi species, serological reagent and equipment. It is a Class I device, regulated under 21 CFR 866.3720 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under LHW, from 2 different applicants. The average 510(k) review took 18 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment |
| Device class | Class I |
| Regulation | 21 CFR 866.3720 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LHW clearance
Top LHW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Blue Ridge Media Co. | 2 | 1982-04-16 |
| Dutchland Laboratories, Inc. | 2 | 1981-12-31 |
Most recent LHW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K820849 | Blue Ridge Media Co. | BLUE RIDGE RABBIT BLOOD | 1982-04-16 | 21 |
| K820848 | Blue Ridge Media Co. | BLUE RIDGE SHEEP BLOOD | 1982-04-16 | 21 |
| K813513 | Dutchland Laboratories, Inc. | AFRICAN GREEN MONKEY BLOOD IN ALSERVERS | 1981-12-31 | 16 |
| K813512 | Dutchland Laboratories, Inc. | RHESUS MONKEY BLOOD IN ALSEVER'S | 1981-12-29 | 14 |
Recalls for LHW devices
openFDA lists no recalls for product code LHW.
Frequently asked questions
What is FDA product code LHW?
LHW is the FDA product code for erythrocyte suspension, multi species, serological reagent and equipment. It is a Class I device, regulated under 21 CFR 866.3720 and reviewed by the Microbiology panel.
What device class is LHW?
Class I, regulation 21 CFR 866.3720. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LHW?
Across 4 cleared submissions the average was 18 days from receipt to decision (median 18).
Which companies have the most LHW clearances?
Blue Ridge Media Co. (2); Dutchland Laboratories, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LHW
- Run a recall and safety report across every LHW manufacturer
- Watch product code LHW 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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