Microbiological Research Corp.: FDA clearances and approvals
Microbiological Research Corp. has 14 FDA 510(k) clearances (first 1977, latest 1989), across 13 product codes in 4 review panels. Median 510(k) review time: 73 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 |
|---|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | 2 |
| DEW | Igg, Antigen, Antiserum, Control | 1 | 1 |
| GLZ | Antigens, If, Toxoplasma Gondii | 1 | 1 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 1 | 1 |
| GOL | Antigen, Ha (Including Ha Control), Rubella | 1 | 1 |
| GQI | Antiserum, Cf, Cytomegalovirus | 1 | 1 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 1 | 1 |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 1 | 1 |
| JNO | N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin | 1 | 1 |
| LEB | Mounting Media | 1 | 1 |
Plus 3 more product codes.
Review panels
- Microbiology (11)
- Clinical Chemistry (1)
- Immunology (1)
- Pathology (1)
Most recent Microbiological Research Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883011 | MRI NEO-TRYP TRYPSIN RIA | JNO | 1989-04-26 | 281 |
| K861123 | THE GOLDEN QUAD TEST (CMV) | GQI | 1987-02-02 | 314 |
| K861122 | THE GOLDEN QUAD TEST (TOXO) | LJK | 1987-02-02 | 314 |
| K861121 | THE GOLDEN QUAD TEST (EBV) | GNP | 1987-02-02 | 314 |
| K861120 | THE GOLDEN QUAD TEST (HSV) | GQO | 1987-02-02 | 314 |
| K860450 | THE CMV-IGM TEST | LKQ | 1986-05-13 | 98 |
| K843138 | CMV TEST | LIN | 1985-01-29 | 173 |
| K821018 | ANTIHUMAN IGG GLOBULIN FITC LABELED | DEW | 1982-04-29 | 17 |
| K821019 | PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU | LEB | 1982-04-26 | 14 |
| K803175 | RUBELLA VIRUS SEROLOGICAL REAGENTS | LFX | 1981-01-29 | 45 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Microbiological Research Corp..
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 Microbiological Research Corp. have?
Microbiological Research Corp. has 14 FDA 510(k) clearances (first 1977, latest 1989), across 13 product codes in 4 review panels.
How long does FDA take to clear Microbiological Research Corp.'s 510(k)s?
The median time from FDA receipt to decision across Microbiological Research Corp.'s cleared 510(k)s is 73 days.
What devices does Microbiological Research Corp. make?
Its most frequent FDA product codes are LFX (Enzyme Linked Immunoabsorbent Assay, Rubella, 2); DEW (Igg, Antigen, Antiserum, Control, 1); GLZ (Antigens, If, Toxoplasma Gondii, 1).
Has Microbiological Research Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Microbiological Research Corp. Related entities may recall under other names.
Next steps
- See all 14 Microbiological Research Corp. clearances with predicates and recalls
- Run predicate analysis for product code LFX, Microbiological Research Corp.'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.