Micro Detect, Inc.: FDA clearances and approvals
Micro Detect, Inc. has 11 FDA 510(k) clearances (first 1998, latest 2001), across 6 product codes in 2 review panels. Median 510(k) review time: 75 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 3 | 3 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | 2 |
| LYR | Helicobacter Pylori | 2 | 2 |
| MST | Antibodies, Gliadin | 2 | 2 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 1 | 1 |
Review panels
- Immunology (9)
- Microbiology (2)
Most recent Micro Detect, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003794 | ELISA TEST, SEROLOGY | LYR | 2001-03-30 | 112 |
| K002359 | MDI GLIADIN G TEST | MST | 2000-10-19 | 78 |
| K002358 | MDI GLIADIN A TEST | MST | 2000-10-19 | 78 |
| K000934 | MDI SCL-70 TEST | LJM | 2000-04-07 | 15 |
| K000477 | MDI DS-DNA TEST | LRM | 2000-03-01 | 16 |
| K994029 | MDI SM TEST | LLL | 2000-01-11 | 46 |
| K993971 | MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM | LLL | 2000-01-11 | 49 |
| K993843 | MDI RF TEST | DHR | 2000-01-11 | 60 |
| K993636 | MDI SS-A TEST | LJM | 2000-01-10 | 75 |
| K993635 | MDI SM/RNP TEST | LJM | 2000-01-10 | 75 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Micro Detect, Inc..
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 Detect, Inc. have?
Micro Detect, Inc. has 11 FDA 510(k) clearances (first 1998, latest 2001), across 6 product codes in 2 review panels.
How long does FDA take to clear Micro Detect, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Micro Detect, Inc.'s cleared 510(k)s is 75 days.
What devices does Micro Detect, Inc. make?
Its most frequent FDA product codes are LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 3); LLL (Extractable Antinuclear Antibody, Antigen And Control, 2); LYR (Helicobacter Pylori, 2).
Has Micro Detect, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Micro Detect, Inc. Related entities may recall under other names.
Next steps
- See all 11 Micro Detect, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJM, Micro Detect, Inc.'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.