Microbix Biosystems, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Microbix Biosystems, Inc.” (first 1985, latest 1989), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 126 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 |
|---|---|---|---|
| GMN | Antigens, Cf, Toxoplasma Gondii | 1 | 1 |
| GON | Antigen, Cf (Including Cf Control), Rubella | 1 | 1 |
| GQI | Antiserum, Cf, Cytomegalovirus | 1 | 1 |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 1 | 1 |
| GQX | Antiserum, Cf, Varicella-Zoster | 1 | 1 |
| GRF | Antiserum, Cf, Rubeola | 1 | 1 |
| GSB | Antigens, Cf, All, Mycoplasma Spp. | 1 | 1 |
Review panels
- Microbiology (7)
Most recent Microbix Biosystems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K894262 | RUBELLA ANTIGEN AND CONTROL ANTIGEN | GON | 1989-10-16 | 117 |
| K894261 | TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN | GMN | 1989-10-16 | 117 |
| K852932 | MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT | GRF | 1985-11-12 | 126 |
| K852931 | HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT | GQO | 1985-11-12 | 126 |
| K852930 | VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO | GQX | 1985-11-12 | 126 |
| K852929 | CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR | GQI | 1985-11-12 | 126 |
| K852933 | MYCOPLASMA SPP SEROLOGICAL REAGENTS | GSB | 1985-08-01 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Microbix Biosystems, 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 Microbix Biosystems, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Microbix Biosystems, Inc.” (first 1985, latest 1989), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Microbix Biosystems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microbix Biosystems, Inc. is 126 days.
Which FDA product codes appear under Microbix Biosystems, Inc.?
The most frequent FDA product codes under this applicant name are GMN (Antigens, Cf, Toxoplasma Gondii, 1); GON (Antigen, Cf (Including Cf Control), Rubella, 1); GQI (Antiserum, Cf, Cytomegalovirus, 1).
Next steps
- See all 7 Microbix Biosystems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GMN, Microbix Biosystems, 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.