Biostar, Inc.: FDA clearances and approvals
Biostar, Inc. has 6 FDA 510(k) clearances (first 1994, latest 1999), across 5 product codes in 1 review panel. Median 510(k) review time: 196 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 |
|---|---|---|---|
| GTY | Antigens, All Groups, Streptococcus Spp. | 2 | 2 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 1 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 | 1 |
| LLH | Reagents, Clostridium Difficile Toxin | 1 | 1 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 1 | 1 |
Review panels
- Microbiology (6)
Most recent Biostar, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991829 | CDTOX A OIA | LLH | 1999-11-02 | 158 |
| K991828 | STREP B OIA | GTY | 1999-08-19 | 83 |
| K981651 | AB FLU OIA | PSZ | 1998-11-25 | 198 |
| K962060 | STREP A OIA MAX | GTZ | 1997-07-23 | 421 |
| K951010 | CHLAMYDIA OIA | LJC | 1995-10-07 | 215 |
| K936112 | STREP B OIA | GTY | 1994-07-06 | 195 |
Recalls
openFDA lists no recalls under a recalling firm named Biostar, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Biostar, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Biostar, Inc. have?
Biostar, Inc. has 6 FDA 510(k) clearances (first 1994, latest 1999), across 5 product codes in 1 review panel.
How long does FDA take to clear Biostar, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Biostar, Inc.'s cleared 510(k)s is 196 days.
What devices does Biostar, Inc. make?
Its most frequent FDA product codes are GTY (Antigens, All Groups, Streptococcus Spp., 2); GTZ (Antisera, All Groups, Streptococcus Spp., 1); LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), 1).
Has Biostar, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biostar, Inc. Related entities may recall under other names.
Next steps
- See all 6 Biostar, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GTY, Biostar, 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.