Antibodies, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Antibodies, Inc.” (first 1977, latest 1989), across 14 product codes in 4 review panels. Median 510(k) review time under this name: 33 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 |
|---|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 3 | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DJB | Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. | 1 | 1 |
| DNJ | Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep. | 1 | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| KHW | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | 1 | 1 |
Plus 4 more product codes.
Review panels
- Immunology (5)
- Clinical Toxicology (5)
- Clinical Chemistry (3)
- Microbiology (2)
Most recent Antibodies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890774 | GIARDEIA(TM) | KHW | 1989-04-04 | 48 |
| K843590 | DETECT-A-STREP | GTZ | 1984-10-30 | 48 |
| K822892 | CORTISOL RIA KIT | CGR | 1982-11-01 | 34 |
| K812749 | ULTRA-DIG | LCS | 1981-10-19 | 20 |
| K812314 | CRITHIDNA ANTI-DNA TEST KIT | DHN | 1981-09-01 | 15 |
| K802877 | AMIKACIN RIA KIT | KLQ | 1980-12-19 | 32 |
| K800743 | TOBRAMYCIN RIA KIT | KLB | 1980-04-16 | 13 |
| K791217 | TSH RIA KIT | JLW | 1979-09-04 | 64 |
| K781656 | NEPHELRATE ANTISERUMS, IGG | CFN | 1978-11-08 | 42 |
| K781655 | NEPHELRATE ANTISERUMS 1GA | CFN | 1978-11-08 | 42 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Antibodies, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Antibodies, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Antibodies, Inc.” (first 1977, latest 1989), across 14 product codes in 4 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 Antibodies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Antibodies, Inc. is 33 days.
Which FDA product codes appear under Antibodies, Inc.?
The most frequent FDA product codes under this applicant name are CFN (Method, Nephelometric, Immunoglobulins (G, A, M), 3); CDP (Radioimmunoassay, Total Triiodothyronine, 1); CGR (Radioimmunoassay, Cortisol, 1).
Next steps
- See all 16 Antibodies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CFN, Antibodies, Inc.'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.