FDA product code LHL: Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
LHL is the FDA product code for reagents, antibody, legionella, direct & indirect fluorescent. It is a Class II device, regulated under 21 CFR 866.3300 and reviewed by the Microbiology panel. FDA has cleared 18 510(k) submissions under LHL, from 11 different applicants. The average 510(k) review took 92 days (median 76). FDA has posted 3 recalls for LHL devices.
Classification
| Field | Value |
|---|---|
| Device name | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Device class | Class II |
| Regulation | 21 CFR 866.3300 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LHL clearance
Top LHL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeus Scientific, Inc. | 2 | 1999-01-11 |
| Medical Diagnostic Technologies, Inc. | 2 | 1987-04-20 |
| Genetic Systems Corp. | 2 | 1985-08-22 |
| Biodan Medical Systems, Ltd. | 2 | 1983-10-14 |
| Bionetic Laboratory Products | 2 | 1983-08-08 |
6 more applicants have LHL clearances. See the full list in Caduvo.
Most recent LHL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K984123 | Zeus Scientific, Inc. | THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E | 1999-01-11 | 54 |
| K970149 | Zeus Scientific, Inc. | LEGIONELLA ELISA TEST SYSTEM | 1997-06-18 | 154 |
| K963318 | Armkel, LLC | LEGIONELLA IGG/IGM ELISA TEST SYSTEM | 1997-03-03 | 192 |
| K921421 | Pro-Lab, Inc. | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY | 1992-07-28 | 126 |
| K871328 | E.I. Dupont DE Nemours & Co., Inc. | DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT | 1987-09-02 | 152 |
Recalls for LHL devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-02-15.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code LHL?
LHL is the FDA product code for reagents, antibody, legionella, direct & indirect fluorescent. It is a Class II device, regulated under 21 CFR 866.3300 and reviewed by the Microbiology panel.
What device class is LHL?
Class II, regulation 21 CFR 866.3300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LHL?
Across 18 cleared submissions the average was 92 days from receipt to decision (median 76).
Which companies have the most LHL clearances?
Zeus Scientific, Inc. (2); Medical Diagnostic Technologies, Inc. (2); Genetic Systems Corp. (2); Biodan Medical Systems, Ltd. (2); Bionetic Laboratory Products (2).
Have LHL devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2017-02-15.
Next steps
- Run an FDA pathway report with predicate devices for product code LHL
- Run a recall and safety report across every LHL manufacturer
- Watch product code LHL 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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