Ivd Research, Inc.: FDA clearances and approvals
Ivd Research, Inc. has 5 FDA 510(k) clearances (first 2002, latest 2009), across 3 product codes in 1 review panel. Median 510(k) review time: 208 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 |
|---|---|---|---|
| MHI | Giardia Spp. | 3 | 3 |
| LLH | Reagents, Clostridium Difficile Toxin | 1 | 1 |
| MHJ | Cryptosporidium Spp. | 1 | 1 |
Review panels
- Microbiology (5)
Most recent Ivd Research, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081064 | GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF | MHI | 2009-01-14 | 275 |
| K032897 | C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 | LLH | 2004-05-27 | 253 |
| K031059 | IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 | MHJ | 2003-07-10 | 104 |
| K024113 | IVD CRYPTO/GIARDIA DFA | MHI | 2003-03-05 | 82 |
| K020583 | IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 | MHI | 2002-09-17 | 208 |
Recalls
openFDA lists no recalls under a recalling firm named Ivd Research, 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 Ivd Research, Inc. have?
Ivd Research, Inc. has 5 FDA 510(k) clearances (first 2002, latest 2009), across 3 product codes in 1 review panel.
How long does FDA take to clear Ivd Research, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ivd Research, Inc.'s cleared 510(k)s is 208 days.
What devices does Ivd Research, Inc. make?
Its most frequent FDA product codes are MHI (Giardia Spp., 3); LLH (Reagents, Clostridium Difficile Toxin, 1); MHJ (Cryptosporidium Spp., 1).
Has Ivd Research, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ivd Research, Inc. Related entities may recall under other names.
Next steps
- See all 5 Ivd Research, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MHI, Ivd Research, 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.