Hf Scientific, Inc.: FDA clearances and approvals
Hf Scientific, Inc. has 5 FDA 510(k) clearances (first 1987, latest 1988), across 3 product codes in 2 review panels. Median 510(k) review time: 71 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 |
|---|---|---|---|
| CIE | Volumetric/Manometric, Carbon-Dioxide | 2 | 2 |
| JGS | Electrode, Ion Specific, Sodium | 2 | 2 |
| GIQ | Hemoglobin S | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Hematology (1)
Most recent Hf Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882801 | RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN. | JGS | 1988-08-29 | 53 |
| K880967 | MICRO CO2 APPARATUS | CIE | 1988-04-28 | 51 |
| K874429 | HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 | GIQ | 1988-02-04 | 99 |
| K864313 | CO2 REAGENT SET | CIE | 1987-03-13 | 130 |
| K864862 | REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA. | JGS | 1987-02-20 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Hf Scientific, Inc..
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 Hf Scientific, Inc. have?
Hf Scientific, Inc. has 5 FDA 510(k) clearances (first 1987, latest 1988), across 3 product codes in 2 review panels.
How long does FDA take to clear Hf Scientific, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hf Scientific, Inc.'s cleared 510(k)s is 71 days.
What devices does Hf Scientific, Inc. make?
Its most frequent FDA product codes are CIE (Volumetric/Manometric, Carbon-Dioxide, 2); JGS (Electrode, Ion Specific, Sodium, 2); GIQ (Hemoglobin S, 1).
Has Hf Scientific, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hf Scientific, Inc. Related entities may recall under other names.
Next steps
- See all 5 Hf Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CIE, Hf Scientific, Inc.'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.