Biologics Intl., Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Biologics Intl., Inc.” (first 1979, latest 1988), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 | 2 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| DHC | System, Test, Systemic Lupus Erythematosus | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | 1 |
| IOQ | Bed, Flotation Therapy, Powered | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| JSG | Culture Media, Non-Selective And Non-Differential | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- Immunology (3)
- Microbiology (2)
- Physical Medicine (1)
Most recent Biologics Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882229 | AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS | IOQ | 1988-08-16 | 88 |
| K823353 | CARCINO-CEK | JJX | 1982-12-14 | 35 |
| K812060 | BI-ASO SLIDE TEST | GTQ | 1981-08-13 | 23 |
| K811375 | BI-RA SLIDE TEST | DHR | 1981-06-12 | 28 |
| K811374 | BI-CRP LATEX TEST | DCN | 1981-06-12 | 28 |
| K800605 | ANA LATEX SLIDE TEST | DHC | 1980-04-02 | 16 |
| K791609 | BE-SURE | JHJ | 1979-10-02 | 53 |
| K791607 | BETA-CELL | JSG | 1979-09-24 | 41 |
| K790898 | PREG-TEX | JHJ | 1979-07-30 | 82 |
Recalls
openFDA lists no recalls under a recalling firm named Biologics Intl., 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 Biologics Intl., Inc.?
FDA lists 9 510(k) clearances under the applicant name “Biologics Intl., Inc.” (first 1979, latest 1988), across 8 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 Biologics Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biologics Intl., Inc. is 35 days.
Which FDA product codes appear under Biologics Intl., Inc.?
The most frequent FDA product codes under this applicant name are JHJ (Agglutination Method, Human Chorionic Gonadotropin, 2); DCN (System, Test, C-Reactive Protein, 1); DHC (System, Test, Systemic Lupus Erythematosus, 1).
Next steps
- See all 9 Biologics Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHJ, Biologics Intl., 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.