American Laboratory Products Co., Ltd.: FDA clearances and approvals
American Laboratory Products Co., Ltd. has 27 FDA 510(k) clearances (first 1991, latest 2002), across 10 product codes in 2 review panels. Median 510(k) review time: 95 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 |
|---|---|---|---|
| JZO | System, Test, Thyroid Autoantibody | 9 | 9 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 6 | 6 |
| MID | System, Test, Anticardiolipin Immunological | 3 | 3 |
| KQN | Radioassay, Angiotensin Converting Enzyme | 2 | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | 2 |
| CDD | Radioassay, Vitamin B12 | 1 | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | 1 |
| DAK | Complement C1q, Antigen, Antiserum, Control | 1 | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 1 | 1 |
Review panels
- Immunology (22)
- Clinical Chemistry (5)
Most recent American Laboratory Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012576 | CIC-C1Q EIA | DAK | 2002-01-29 | 173 |
| K011415 | ALPCO MILENIA ANTI-TG EIA | JZO | 2001-05-30 | 22 |
| K011201 | ALPCO MILENIA ANTI-TPO ELISA | JZO | 2001-05-24 | 35 |
| K974702 | ORGENTEC ANTI-PR3 (C-ANCA) ELISA | MOB | 1998-02-17 | 71 |
| K974701 | ORGENTEC ANTI-MPO (P-ANCA) ELISA | MOB | 1998-02-17 | 71 |
| K972190 | THYROGLOBULIN ASSAY SYSTEM | JZO | 1997-07-14 | 56 |
| K970932 | ORGENTEC MICRO-ALBUMIN EIA ASSAY | JIR | 1997-04-08 | 47 |
| K962062 | ORGENTEC ANTI-SM ELISA | LJM | 1996-11-18 | 174 |
| K962057 | ORGENTEC ANTI-RNP/SM ELISA | LJM | 1996-11-18 | 174 |
| K962055 | ORGENTEC ANTI-SCL 70 ELISA | LJM | 1996-11-15 | 171 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Laboratory Products Co., Ltd..
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 American Laboratory Products Co., Ltd. have?
American Laboratory Products Co., Ltd. has 27 FDA 510(k) clearances (first 1991, latest 2002), across 10 product codes in 2 review panels.
How long does FDA take to clear American Laboratory Products Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across American Laboratory Products Co., Ltd.'s cleared 510(k)s is 95 days.
What devices does American Laboratory Products Co., Ltd. make?
Its most frequent FDA product codes are JZO (System, Test, Thyroid Autoantibody, 9); LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 6); MID (System, Test, Anticardiolipin Immunological, 3).
Has American Laboratory Products Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching American Laboratory Products Co., Ltd. Related entities may recall under other names.
Next steps
- See all 27 American Laboratory Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JZO, American Laboratory Products Co., Ltd.'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.