Micromedic Systems: FDA filings under this applicant name
FDA lists 42 510(k) clearances under the applicant name “Micromedic Systems” (first 1976, latest 1993), across 19 product codes in 5 review panels. Median 510(k) review time under this name: 44 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 8 | 8 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 6 | 6 |
| CDX | Radioimmunoassay, Total Thyroxine | 4 | 4 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 4 | 4 |
| CDD | Radioassay, Vitamin B12 | 2 | 2 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 2 | 2 |
| CGI | Radioimmunoassay, Estriol | 2 | 2 |
| DBF | Ferritin, Antigen, Antiserum, Control | 2 | 2 |
| KHQ | Radioassay, Triiodothyronine Uptake | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
Plus 9 more product codes.
Review panels
- Clinical Chemistry (36)
- Immunology (2)
- Microbiology (1)
- Physical Medicine (1)
- Clinical Toxicology (1)
Most recent Micromedic Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923643 | MEDICOOL | ILO | 1993-03-31 | 253 |
| K872309 | MICROMEDIC COMBOSTAT LH/FSH KIT | CGJ | 1987-07-31 | 45 |
| K871505 | AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT | JLW | 1987-05-26 | 39 |
| K871008 | MICROMEDIC NEONATAL T4 KIT | CDX | 1987-05-26 | 74 |
| K870904 | MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT | JLW | 1987-05-26 | 82 |
| K870245 | AUTOPAK TSH MONOCLONAL IRMA KIT | JLW | 1987-04-01 | 70 |
| K862206 | TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER | JJJ | 1986-08-04 | 55 |
| K860813 | MICROMEDIC HTSH MONOCLONAL IRMA KIT | JLW | 1986-07-14 | 132 |
| K861262 | MMS T3 UPTAKE | KHQ | 1986-05-23 | 49 |
| K861320 | MMS T4 RIA KIT | CDX | 1986-04-24 | 16 |
32 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Micromedic Systems.
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 Micromedic Systems?
FDA lists 42 510(k) clearances under the applicant name “Micromedic Systems” (first 1976, latest 1993), across 19 product codes in 5 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 Micromedic Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micromedic Systems is 44 days.
Which FDA product codes appear under Micromedic Systems?
The most frequent FDA product codes under this applicant name are JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 8); JQW (Station, Pipetting And Diluting, For Clinical Use, 6); CDX (Radioimmunoassay, Total Thyroxine, 4).
Next steps
- See all 42 Micromedic Systems clearances with predicates and recalls
- Run predicate analysis for product code JLW, Micromedic Systems'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.