FDA product code LKH: Antisera, Immunoperoxidase, Chlamydia Spp.
LKH is the FDA product code for antisera, immunoperoxidase, chlamydia spp.. It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel. FDA has cleared 8 510(k) submissions under LKH, from 7 different applicants. The average 510(k) review took 126 days (median 57). FDA has posted 6 recalls for LKH devices.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Immunoperoxidase, Chlamydia Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3120 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top LKH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Savyon Diagnostics , Ltd. | 2 | 1991-03-19 |
| Icn Immunobiologicals | 1 | 1989-08-15 |
| Difco Laboratories, Inc. | 1 | 1989-06-23 |
| Scott Laboratories, Inc. | 1 | 1985-09-19 |
| Bartels Immunodiagnostic Supplies, Inc. | 1 | 1984-07-20 |
2 more applicants have LKH clearances. See the full list in Caduvo.
Most recent LKH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K910644 | Savyon Diagnostics , Ltd. | IPAZYME (TM) CHLAMYDIA IGG-IGA | 1991-03-19 | 33 |
| K901975 | Savyon Diagnostics , Ltd. | IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) | 1991-03-08 | 311 |
| K882674 | Icn Immunobiologicals | IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT | 1989-08-15 | 413 |
| K893669 | Difco Laboratories, Inc. | CELLMATICS SHLAMYDIA DETECTION SYSTEM | 1989-06-23 | 39 |
| K852869 | Scott Laboratories, Inc. | SELECTICULT-CHLAMYDIA | 1985-09-19 | 73 |
Recalls for LKH devices
6 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-08-15.
Frequently asked questions
What is FDA product code LKH?
LKH is the FDA product code for antisera, immunoperoxidase, chlamydia spp.. It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel.
What device class is LKH?
Class I, regulation 21 CFR 866.3120. Typical premarket route: 510(k).
How long does a 510(k) take for product code LKH?
Across 8 cleared submissions the average was 126 days from receipt to decision (median 57).
Which companies have the most LKH clearances?
Savyon Diagnostics , Ltd. (2); Icn Immunobiologicals (1); Difco Laboratories, Inc. (1); Scott Laboratories, Inc. (1); Bartels Immunodiagnostic Supplies, Inc. (1).
Have LKH devices been recalled?
Yes: 6 product recalls across 1 recall events; the most recent began 2006-08-15.
Next steps
- Run an FDA pathway report with predicate devices for product code LKH
- Run a recall and safety report across every LKH manufacturer
- Watch product code LKH 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.