FDA product code LHT: Staphylococcus Aureus Somatic Antigens
LHT is the FDA product code for staphylococcus aureus somatic antigens. It is a Class I device, regulated under 21 CFR 866.3700 and reviewed by the Microbiology panel. FDA has cleared 13 510(k) submissions under LHT, from 7 different applicants. The average 510(k) review took 25 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Staphylococcus Aureus Somatic Antigens |
| Device class | Class I |
| Regulation | 21 CFR 866.3700 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LHT clearance
Top LHT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dutchland Laboratories, Inc. | 7 | 1981-09-09 |
| Oxoid U.S.A., Inc. | 1 | 1987-11-06 |
| Scott Laboratories, Inc. | 1 | 1986-09-15 |
| American Scientific Products | 1 | 1982-04-14 |
| Meridian Diagnostics, Inc. | 1 | 1982-04-14 |
2 more applicants have LHT clearances. See the full list in Caduvo.
Most recent LHT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874303 | Oxoid U.S.A., Inc. | STAPHYLASE TEST | 1987-11-06 | 17 |
| K863025 | Scott Laboratories, Inc. | SERO-STAT R II STAPHYLOCOCCUS TEST | 1986-09-15 | 35 |
| K820531 | Meridian Diagnostics, Inc. | ENDO-STAPH TEICHOIC ACID ANTIBODY KIT | 1982-04-14 | 43 |
| K820683 | American Scientific Products | STAPHYLOCOCCUS LATEX AGGLUTINATION KIT | 1982-04-14 | 34 |
| K820347 | Carr-Scarborough Microbiologicals, Inc. | ACCU-STAPH | 1982-03-04 | 24 |
Recalls for LHT devices
openFDA lists no recalls for product code LHT.
Frequently asked questions
What is FDA product code LHT?
LHT is the FDA product code for staphylococcus aureus somatic antigens. It is a Class I device, regulated under 21 CFR 866.3700 and reviewed by the Microbiology panel.
What device class is LHT?
Class I, regulation 21 CFR 866.3700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LHT?
Across 13 cleared submissions the average was 25 days from receipt to decision (median 20).
Which companies have the most LHT clearances?
Dutchland Laboratories, Inc. (7); Oxoid U.S.A., Inc. (1); Scott Laboratories, Inc. (1); American Scientific Products (1); Meridian Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LHT
- Run a recall and safety report across every LHT manufacturer
- Watch product code LHT 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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