Biodiagnostic Intl: FDA clearances and approvals
Biodiagnostic Intl has 11 FDA 510(k) clearances (first 1983, latest 2004), across 8 product codes in 3 review panels. Median 510(k) review time: 54 days.
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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 | 3 |
| DIF | Drug Mixture Control Materials | 2 | 2 |
| DKB | Calibrators, Drug Mixture | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 1 | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 | 1 |
Review panels
- Clinical Chemistry (6)
- Clinical Toxicology (3)
- Hematology (2)
Most recent Biodiagnostic Intl 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031296 | LIQUI-HEME GLYCO A1C ASSAY | LCP | 2004-10-15 | 541 |
| K881430 | LIQUI-SERA SERUM ALCOHOL CONTROLS | JJX | 1988-07-08 | 94 |
| K874459 | LIQUI-SERA SPINAL FLUID CONTROL | JJY | 1987-12-29 | 61 |
| K863849 | LIQUI-SERA COMBO LIGAND/TDM CONTROLS | JJY | 1986-11-24 | 55 |
| K853906 | LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) | JJY | 1985-10-04 | 14 |
| K853887 | LIQUI-SERA CHEM. MULTIPLE CALIBRATORS | JIT | 1985-09-30 | 11 |
| K842668 | LIQUI-HEME HEMOGLOBIN CALIBRATORS | KRZ | 1985-03-05 | 238 |
| K840618 | LIQUI-URA CHEMISTRY URINE CONTROLS | JJW | 1984-04-04 | 50 |
| K834398 | LIQUI-SERA TDM CALIBRATORS | DKB | 1984-02-03 | 51 |
| K834259 | LIQUI-URA TOXIC URINE CONTROL | DIF | 1984-01-30 | 54 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biodiagnostic Intl.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Biodiagnostic Intl have?
Biodiagnostic Intl has 11 FDA 510(k) clearances (first 1983, latest 2004), across 8 product codes in 3 review panels.
How long does FDA take to clear Biodiagnostic Intl's 510(k)s?
The median time from FDA receipt to decision across Biodiagnostic Intl's cleared 510(k)s is 54 days.
What devices does Biodiagnostic Intl make?
Its most frequent FDA product codes are JJY (Multi-Analyte Controls, All Kinds (Assayed), 3); DIF (Drug Mixture Control Materials, 2); DKB (Calibrators, Drug Mixture, 1).
Has Biodiagnostic Intl had device recalls?
openFDA lists no recalls under a recalling firm name matching Biodiagnostic Intl. Related entities may recall under other names.
Next steps
- See all 11 Biodiagnostic Intl clearances with predicates and recalls
- Run predicate analysis for product code JJY, Biodiagnostic Intl's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.