Bhp Diagnostix, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Bhp Diagnostix, Inc.” (first 1978, latest 1990), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 42 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 11 | 11 |
| JPK | Mixture, Hematology Quality Control | 7 | 7 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 | 4 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 | 3 |
Review panels
- Clinical Chemistry (18)
- Hematology (7)
Most recent Bhp Diagnostix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K904503 | SERACON CR REFERENCE | JJX | 1990-11-02 | 31 |
| K863648 | SERACON CT REFERENCE | JJY | 1986-10-29 | 41 |
| K862594 | SERACON(TM) CAL (PRODUCT NO. DO35) | JIX | 1986-08-19 | 42 |
| K844928 | QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE | JPK | 1985-03-22 | 93 |
| K844927 | QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS | JPK | 1985-03-22 | 93 |
| K844027 | SERACON TM SR III | JIX | 1984-11-27 | 43 |
| K844026 | SERACON TM SR IV | JIX | 1984-11-27 | 43 |
| K792487 | SERACON-SRII | JIX | 1979-12-31 | 28 |
| K792486 | SERACON-SRI (PROD. # D029 | JIX | 1979-12-31 | 28 |
| K792485 | SERACON-SRI | JIX | 1979-12-31 | 28 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bhp Diagnostix, 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 Bhp Diagnostix, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Bhp Diagnostix, Inc.” (first 1978, latest 1990), across 4 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 Bhp Diagnostix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bhp Diagnostix, Inc. is 42 days.
Which FDA product codes appear under Bhp Diagnostix, Inc.?
The most frequent FDA product codes under this applicant name are JIX (Calibrator, Multi-Analyte Mixture, 11); JPK (Mixture, Hematology Quality Control, 7); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 4).
Next steps
- See all 25 Bhp Diagnostix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIX, Bhp Diagnostix, 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.