Monoclonal Antibodies, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Monoclonal Antibodies, Inc.” (first 1982, latest 1988), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | 4 | 4 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 4 | 4 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 3 | 3 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 | 1 |
Review panels
- Clinical Chemistry (13)
- Microbiology (1)
Most recent Monoclonal Antibodies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874863 | RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) | GQN | 1988-02-16 | 83 |
| K871726 | OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) | CEP | 1987-07-27 | 83 |
| K863744 | HCG CONTROL KIT | JJX | 1986-11-05 | 42 |
| K860924 | RAMP PROGESTURINE PDG ASSAY--48 TEST KIT | JLS | 1986-07-02 | 113 |
| K854611 | RAMP URINE HCG ASSAY | JHI | 1985-12-30 | 42 |
| K850730 | MODEL SERUM HCG ASSAY | JHI | 1985-04-02 | 39 |
| K850480 | OVU STICK SELF-TEST -MODIFICATION | CEP | 1985-03-05 | 34 |
| K843284 | OVUSTICK SELF-TEST | CEP | 1984-12-11 | 113 |
| K840738 | PLUS URINE HCG ASSAY | JHJ | 1984-04-19 | 58 |
| K840412 | OVU STICK URINE HLH KIT | CEP | 1984-04-13 | 73 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Monoclonal 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 Monoclonal Antibodies, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Monoclonal Antibodies, Inc.” (first 1982, latest 1988), across 6 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 Monoclonal Antibodies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Monoclonal Antibodies, Inc. is 56 days.
Which FDA product codes appear under Monoclonal Antibodies, Inc.?
The most frequent FDA product codes under this applicant name are CEP (Radioimmunoassay, Luteinizing Hormone, 4); JHI (Visual, Pregnancy Hcg, Prescription Use, 4); JHJ (Agglutination Method, Human Chorionic Gonadotropin, 3).
Next steps
- See all 14 Monoclonal Antibodies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEP, Monoclonal 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, 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.