Microprobe Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Microprobe Corp.” (first 1992, latest 1993), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 96 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 |
|---|---|---|---|
| MLA | Dna Probe, Yeast | 2 | 2 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | 1 |
| LIO | Device, Specimen Collection | 1 | 1 |
| MJK | Dna Probe, Trichomonas Vaginalis | 1 | 1 |
| MJM | Dna Probe, Gardnerella Vaginalis | 1 | 1 |
Review panels
- Microbiology (5)
- Clinical Chemistry (1)
Most recent Microprobe Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931151 | AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA | MLA | 1993-06-18 | 102 |
| K931374 | AFFIRM VPIII MICROBIAL IDENTIFICATION TEST | MLA | 1993-06-15 | 89 |
| K923133 | AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS | MJM | 1992-09-25 | 88 |
| K922457 | AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA | MJK | 1992-09-25 | 122 |
| K923268 | AFFIRM PROCESSOR | JQW | 1992-07-30 | 24 |
| K920536 | AFFIRM VP SAMPLE COLLECTION SET | LIO | 1992-07-30 | 176 |
Recalls
openFDA lists no recalls under a recalling firm named Microprobe Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Microprobe Corp.?
FDA lists 6 510(k) clearances under the applicant name “Microprobe Corp.” (first 1992, latest 1993), across 5 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 Microprobe Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microprobe Corp. is 96 days.
Which FDA product codes appear under Microprobe Corp.?
The most frequent FDA product codes under this applicant name are MLA (Dna Probe, Yeast, 2); JQW (Station, Pipetting And Diluting, For Clinical Use, 1); LIO (Device, Specimen Collection, 1).
Next steps
- See all 6 Microprobe Corp. clearances with predicates and recalls
- Run predicate analysis for product code MLA, Microprobe Corp.'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.