Microbiological Assoc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Microbiological Assoc.” (first 1977, latest 1980), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| GOK | Antisera, Hai (Including Hai Control), Rubella | 2 | 2 |
| GLZ | Antigens, If, Toxoplasma Gondii | 1 | 1 |
| GON | Antigen, Cf (Including Cf Control), Rubella | 1 | 1 |
| GQM | Antisera, Neutralization, Herpesvirus Hominis | 1 | 1 |
| GRE | Antiserum, Fluorescent, Rubeola | 1 | 1 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 1 | 1 |
Plus 1 more product codes.
Review panels
- Microbiology (6)
- Pathology (1)
Most recent Microbiological Assoc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K792133 | RUBELISA TEST KIT | GOK | 1980-01-11 | 81 |
| K791397 | HERPES EIA TEST KIT | GQM | 1979-09-24 | 59 |
| K781549 | TOXELISA TEST KIT | GLZ | 1978-12-07 | 86 |
| K780996 | RUBELISA TEST KIT | GON | 1978-11-22 | 162 |
| K781392 | CYTOMEGILISH TEST KIT | GOK | 1978-10-24 | 75 |
| K781143 | IMMUNOFLUORESCENCE TEST KIT | — | 1978-08-14 | 35 |
| K770764 | TISSUE CULTURE MEDIA W/HEPES BUFFER | KIT | 1977-07-21 | 85 |
| K770687 | MEASLESVIRUS FLOURE. CONJUGATED ANTISERU | GRE | 1977-06-14 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named Microbiological Assoc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Microbiological Research Corp. (14 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Microbiological Assoc.?
FDA lists 8 510(k) clearances under the applicant name “Microbiological Assoc.” (first 1977, latest 1980), across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Microbiological Assoc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microbiological Assoc. is 78 days.
Which FDA product codes appear under Microbiological Assoc.?
The most frequent FDA product codes under this applicant name are GOK (Antisera, Hai (Including Hai Control), Rubella, 2); GLZ (Antigens, If, Toxoplasma Gondii, 1); GON (Antigen, Cf (Including Cf Control), Rubella, 1).
Next steps
- See all 8 Microbiological Assoc. clearances with predicates and recalls
- Run predicate analysis for product code GOK, Microbiological Assoc.'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.