FDA product code LKL: Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
LKL is the FDA product code for alpha-1-acid-glycoprotein, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5420 and reviewed by the Immunology panel. FDA has cleared 11 510(k) submissions under LKL, from 10 different applicants. The average 510(k) review took 87 days (median 57).
Classification
| Field | Value |
|---|---|
| Device name | Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5420 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LKL clearance
Top LKL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Scientific Sales Intl., Inc. | 2 | 1986-12-03 |
| Kamiya Biomedical Co. | 1 | 1999-11-24 |
| Crestat Diagnostics, Inc. | 1 | 1997-07-14 |
| Beckman Instruments, Inc. | 1 | 1997-03-24 |
| The Binding Site, Ltd. | 1 | 1992-08-20 |
5 more applicants have LKL clearances. See the full list in Caduvo.
Most recent LKL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K993441 | Kamiya Biomedical Co. | K-ASSAY ALPHA-1 AG | 1999-11-24 | 43 |
| K964299 | Crestat Diagnostics, Inc. | N-ASSAY TIA MULTI V-NL | 1997-07-14 | 258 |
| K964257 | Beckman Instruments, Inc. | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT | 1997-03-24 | 150 |
| K922417 | The Binding Site, Ltd. | AL-ACID GLYCOPROTEIN RID KIT | 1992-08-20 | 91 |
| K904175 | Reagents Applications, Inc. | RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT | 1990-11-13 | 63 |
Recalls for LKL devices
openFDA lists no recalls for product code LKL.
Frequently asked questions
What is FDA product code LKL?
LKL is the FDA product code for alpha-1-acid-glycoprotein, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5420 and reviewed by the Immunology panel.
What device class is LKL?
Class I, regulation 21 CFR 866.5420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LKL?
Across 11 cleared submissions the average was 87 days from receipt to decision (median 57).
Which companies have the most LKL clearances?
Scientific Sales Intl., Inc. (2); Kamiya Biomedical Co. (1); Crestat Diagnostics, Inc. (1); Beckman Instruments, Inc. (1); The Binding Site, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LKL
- Run a recall and safety report across every LKL manufacturer
- Watch product code LKL 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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