Atlantic Antibodies: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Atlantic Antibodies” (first 1983, latest 1989), across 12 product codes in 2 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| MSJ | Apolipoproteins | 4 | 4 |
| CZP | Iga, Antigen, Antiserum, Control | 2 | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 | 2 |
| JZJ | Prealbumin, Antigen, Antiserum, Control | 2 | 2 |
| CFQ | Radioimmunoassay, Immunoglobulins (G, A, M) | 1 | 1 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 | 1 |
| DBI | Complement C4, Antigen, Antiserum, Control | 1 | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 | 1 |
Plus 2 more product codes.
Review panels
- Immunology (14)
- Clinical Chemistry (4)
Most recent Atlantic Antibodies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K892526 | SPQ TM TEST SYSTEM II FOR CRP | DCK | 1989-05-09 | 28 |
| K891154 | SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B | MSJ | 1989-03-16 | 10 |
| K890563 | SPQ(TM) ANTIBODY REAGENT SET II FOR TRF | DDG | 1989-03-03 | 38 |
| K890561 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGM | CFQ | 1989-02-23 | 30 |
| K890562 | SPQ(TM) ANTIBODY REAGENT SET II FOR HPT | DAD | 1989-02-22 | 29 |
| K890416 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGG | DEW | 1989-02-22 | 29 |
| K890564 | SPQ(TM) ANTIBODY REAGENT SET II FOR C4 | DBI | 1989-02-17 | 24 |
| K890417 | SPQ(TM) ANTIBODY REAGENT SET II FOR C3 | KTQ | 1989-02-17 | 24 |
| K890415 | SPQ(TM) ANTIBODY REAGENT SET II FOR AAT | DEM | 1989-02-17 | 24 |
| K890560 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGA | CZP | 1989-02-15 | 22 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Atlantic Antibodies.
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.
- Atlantic Optical Systems, Inc. (4 510(k)s)
- Atlantic Optical Co., Inc. (3 510(k)s)
- Atlantic Surgical (3 510(k)s)
- Atlantic Health Group (1 510(k)s)
- Atlantic Imaging Corp. (1 510(k)s)
- Atlantic Industries, Inc. (1 510(k)s)
- Atlantic Products, Inc. (1 510(k)s)
- Atlantic Therapeutics, Ltd. (1 510(k)s)
- Atlantic Wholesale, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Atlantic Antibodies?
FDA lists 18 510(k) clearances under the applicant name “Atlantic Antibodies” (first 1983, latest 1989), across 12 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 Atlantic Antibodies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Atlantic Antibodies is 28 days.
Which FDA product codes appear under Atlantic Antibodies?
The most frequent FDA product codes under this applicant name are MSJ (Apolipoproteins, 4); CZP (Iga, Antigen, Antiserum, Control, 2); DCK (C-Reactive Protein, Antigen, Antiserum, And Control, 2).
Next steps
- See all 18 Atlantic Antibodies clearances with predicates and recalls
- Run predicate analysis for product code MSJ, Atlantic Antibodies'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.