Amico Lab, Inc.: FDA clearances and approvals
Amico Lab, Inc. has 32 FDA 510(k) clearances (first 1982, latest 1985), across 12 product codes in 3 review panels. Median 510(k) review time: 75 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DFH | Kappa, Antigen, Antiserum, Control | 14 | 14 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| GNH | Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | 2 | 2 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 2 | 2 |
| GQI | Antiserum, Cf, Cytomegalovirus | 2 | 2 |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 2 | 2 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | 2 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 2 | 2 |
| GLZ | Antigens, If, Toxoplasma Gondii | 1 | 1 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
Plus 2 more product codes.
Review panels
- Immunology (18)
- Microbiology (13)
- Physical Medicine (1)
Most recent Amico Lab, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K842662 | ANTI-EPSTEIN-BARR VIRUS KIT | GNP | 1985-12-12 | 520 |
| K842663 | ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 | GQO | 1985-12-06 | 514 |
| K842661 | ANTI-CYTOMEGALOVIRUS KIT | GQI | 1985-12-06 | 514 |
| K842531 | AMIZYME-HSV TYPES 1 & 2 TEST KITS | GQO | 1985-12-06 | 526 |
| K842530 | AMIZYME-EBV TEST KIT | GNP | 1985-12-06 | 526 |
| K842529 | AMIZYME-CMV KIT | GQI | 1985-12-06 | 526 |
| K842660 | ANTI-SCHISTOSOMA SPECIES KIT | GNH | 1984-10-30 | 112 |
| K842658 | ANTI-CHLAMYDIA TRACHOMATIS KIT | LJP | 1984-10-01 | 83 |
| K842525 | AMIZYME-C TRACHOMATIS TEST KIT | LJP | 1984-10-01 | 95 |
| K842533 | AMIZYME-ANDNA TEST KIT | LJM | 1984-09-20 | 84 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Amico Lab, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Amico Lab, Inc. have?
Amico Lab, Inc. has 32 FDA 510(k) clearances (first 1982, latest 1985), across 12 product codes in 3 review panels.
How long does FDA take to clear Amico Lab, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Amico Lab, Inc.'s cleared 510(k)s is 75 days.
What devices does Amico Lab, Inc. make?
Its most frequent FDA product codes are DFH (Kappa, Antigen, Antiserum, Control, 14); DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 2); GNH (Antigen, Fluorescent Antibody Test, Schistosoma Mansoni, 2).
Has Amico Lab, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Amico Lab, Inc. Related entities may recall under other names.
Next steps
- See all 32 Amico Lab, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DFH, Amico Lab, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.