American Laboratory Products Co., Ltd.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “American Laboratory Products Co., Ltd.” (first 1991, latest 2002), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 95 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Laboratory Products Co., Ltd.?
FDA lists 27 510(k) clearances under the applicant name “American Laboratory Products Co., Ltd.” (first 1991, latest 2002), across 10 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by American Laboratory Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Laboratory Products Co., Ltd. is 95 days.
Which FDA product codes appear under American Laboratory Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are JZO (System, Test, Thyroid Autoantibody, 9); LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 6); MID (System, Test, Anticardiolipin Immunological, 3).
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. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.