Microline Scientific: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Microline Scientific” (first 1984, latest 1984), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 38 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | 3 | 3 |
| JSJ | Culture Media, Selective And Non-Differential | 3 | 3 |
| KZI | Culture Media, Enriched | 3 | 3 |
| JSD | Culture Media, Selective Broth | 1 | 1 |
| JSG | Culture Media, Non-Selective And Non-Differential | 1 | 1 |
| JSH | Culture Media, Non-Selective And Differential | 1 | 1 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 1 | 1 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 1 |
Review panels
- Microbiology (14)
Most recent Microline Scientific 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841845 | SELECTIVE CULTURE MED. COLUMBIA CNA | JSJ | 1984-05-31 | 44 |
| K841844 | DIFFERENTIAL CULTURE MEDIUM-BIGGY AGAR | JSI | 1984-05-31 | 44 |
| K841843 | DIFFERENTIAL CULTURE MED. LEVINE EMB | JSH | 1984-05-31 | 44 |
| K841842 | DIFFERENTIAL CULTURE MED. MACCONKEY AGAR | JSI | 1984-05-31 | 44 |
| K841586 | CHOCOLATE AGAR | KZI | 1984-05-31 | 44 |
| K841841 | DIFFERENTIAL CULTURE MED. MANNITOL SALT | JSI | 1984-05-25 | 38 |
| K841840 | SELECTIVE CULTURE MED. PHENYLETHYL ALCO | JSJ | 1984-05-25 | 38 |
| K841839 | SELECTIVE CULTURE MED. SELECTIVE STREP | JSJ | 1984-05-25 | 38 |
| K841838 | ENRICHED CULTURE MED. TRYPTIC SOY AGAR | KZI | 1984-05-21 | 34 |
| K841837 | ENRICHED CULTURE MED. FLUID THIOGLYC0 | KZI | 1984-05-21 | 34 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Microline Scientific.
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.
- Microline Pentax, Inc. (12 510(k)s)
- Microline Surgical, Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Microline Scientific?
FDA lists 14 510(k) clearances under the applicant name “Microline Scientific” (first 1984, latest 1984), across 8 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 Microline Scientific?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microline Scientific is 38 days.
Which FDA product codes appear under Microline Scientific?
The most frequent FDA product codes under this applicant name are JSI (Culture Media, Selective And Differential, 3); JSJ (Culture Media, Selective And Non-Differential, 3); KZI (Culture Media, Enriched, 3).
Next steps
- See all 14 Microline Scientific clearances with predicates and recalls
- Run predicate analysis for product code JSI, Microline Scientific'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.