Micro-Bio-Logics: FDA clearances and approvals
Micro-Bio-Logics has 9 FDA 510(k) clearances (first 1984, latest 1987), across 7 product codes in 1 review panel. Median 510(k) review time: 19 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 |
|---|---|---|---|
| JTR | Kit, Quality Control For Culture Media | 3 | 3 |
| JSK | Supplement, Culture Media | 1 | 1 |
| JSS | Kit, Identification, Enterobacteriaceae | 1 | 1 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 | 1 |
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | 1 | 1 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 1 | 1 |
| JXA | Kit, Screening, Urine | 1 | 1 |
Review panels
- Microbiology (9)
Most recent Micro-Bio-Logics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870731 | LYFO KWIK(TM) RUS KIT | JXA | 1987-06-17 | 112 |
| K861312 | LYFO-KWIK (TM) COAGULASE PLASMA | JTL | 1986-04-18 | 10 |
| K861022 | KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS | JTR | 1986-04-04 | 17 |
| K855172 | KWI (TM) G-CO/TWO | JSK | 1986-02-20 | 56 |
| K855198 | INDI KWIK (TM) CO/TWO KIT | JTR | 1986-01-14 | 18 |
| K852998 | NEISSERIA - KWIK PLUS | JSX | 1985-07-23 | 8 |
| K851978 | LYFO-KWIK OMI KIT | JSS | 1985-06-04 | 28 |
| K844014 | ONO/CO-TWO (TM) SYSTEMS | JTY | 1984-10-31 | 19 |
| K842129 | LYFO-DISK MICROORGANISMS | JTR | 1984-07-03 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Micro-Bio-Logics.
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 Micro-Bio-Logics have?
Micro-Bio-Logics has 9 FDA 510(k) clearances (first 1984, latest 1987), across 7 product codes in 1 review panel.
How long does FDA take to clear Micro-Bio-Logics's 510(k)s?
The median time from FDA receipt to decision across Micro-Bio-Logics's cleared 510(k)s is 19 days.
What devices does Micro-Bio-Logics make?
Its most frequent FDA product codes are JTR (Kit, Quality Control For Culture Media, 3); JSK (Supplement, Culture Media, 1); JSS (Kit, Identification, Enterobacteriaceae, 1).
Has Micro-Bio-Logics had device recalls?
openFDA lists no recalls under a recalling firm name matching Micro-Bio-Logics. Related entities may recall under other names.
Next steps
- See all 9 Micro-Bio-Logics clearances with predicates and recalls
- Run predicate analysis for product code JTR, Micro-Bio-Logics'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.