Medix Biotech, Inc.: FDA clearances and approvals
Medix Biotech, Inc. has 39 FDA 510(k) clearances (first 1985, latest 1995), across 16 product codes in 3 review panels. Median 510(k) review time: 45 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 9 | 9 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 4 | 4 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 | 3 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 3 | 3 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 | 3 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 3 | 3 |
| CFL | Radioimmunoassay, Human Growth Hormone | 2 | 2 |
| DBF | Ferritin, Antigen, Antiserum, Control | 2 | 2 |
| DGC | Ige, Antigen, Antiserum, Control | 2 | 2 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 | 2 |
Plus 6 more product codes.
Review panels
- Clinical Chemistry (31)
- Immunology (5)
- Microbiology (3)
Most recent Medix Biotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952873 | MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) | GTZ | 1995-09-08 | 94 |
| K952319 | CONTRAST & RAPID HCG URINE/SERUM TST | JHI | 1995-06-20 | 33 |
| K932482 | MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 | GTZ | 1994-07-18 | 420 |
| K932758 | MEDIX BIOTECH BESTEST HCG-URINE TEST KIT | JHI | 1993-09-28 | 117 |
| K925436 | MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT | CDP | 1992-12-28 | 61 |
| K924259 | MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 | JHI | 1992-11-25 | 93 |
| K922047 | IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 | DGC | 1992-08-05 | 96 |
| K921700 | TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 | JLW | 1992-06-29 | 82 |
| K920712 | MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT | KLI | 1992-03-27 | 38 |
| K920345 | PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) | CFT | 1992-03-18 | 51 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medix Biotech, 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 Medix Biotech, Inc. have?
Medix Biotech, Inc. has 39 FDA 510(k) clearances (first 1985, latest 1995), across 16 product codes in 3 review panels.
How long does FDA take to clear Medix Biotech, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medix Biotech, Inc.'s cleared 510(k)s is 45 days.
What devices does Medix Biotech, Inc. make?
Its most frequent FDA product codes are JHI (Visual, Pregnancy Hcg, Prescription Use, 9); CGJ (Radioimmunoassay, Follicle-Stimulating Hormone, 4); CEP (Radioimmunoassay, Luteinizing Hormone, 3).
Has Medix Biotech, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medix Biotech, Inc. Related entities may recall under other names.
Next steps
- See all 39 Medix Biotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Medix Biotech, 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.