FDA product code LHK: Antigen, Id, Candida Albicans
LHK is the FDA product code for antigen, id, candida albicans. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under LHK, from 4 different applicants. The average 510(k) review took 68 days (median 50). FDA has posted 1 recall for LHK devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Id, Candida Albicans |
| Device class | Class II |
| Regulation | 21 CFR 866.3165 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LHK clearance
Top LHK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1989-10-16 |
| Ramco Laboratories, Inc. | 1 | 1982-12-28 |
| Nolan Biological Laboratories, Inc. | 1 | 1981-10-23 |
| American Scientific Products | 1 | 1981-08-25 |
Most recent LHK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893753 | Bd Becton Dickinson Vacutainer Systems Preanalytic | DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST | 1989-10-16 | 150 |
| K823016 | Ramco Laboratories, Inc. | CANDIDA DETECTION SYSTEM | 1982-12-28 | 77 |
| K812741 | Nolan Biological Laboratories, Inc. | REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS | 1981-10-23 | 24 |
| K812186 | American Scientific Products | CANDIDA IMMUNODIFFUSION SYSTEM | 1981-08-25 | 22 |
Recalls for LHK devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code LHK?
LHK is the FDA product code for antigen, id, candida albicans. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel.
What device class is LHK?
Class II, regulation 21 CFR 866.3165. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LHK?
Across 4 cleared submissions the average was 68 days from receipt to decision (median 50).
Which companies have the most LHK clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Ramco Laboratories, Inc. (1); Nolan Biological Laboratories, Inc. (1); American Scientific Products (1).
Have LHK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LHK
- Run a recall and safety report across every LHK manufacturer
- Watch product code LHK 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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