Intercare Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Intercare Diagnostics, Inc.” (first 1986, latest 1994), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 106 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 |
|---|---|---|---|
| LSQ | Reagent, Rickettsia Serological | 2 | 2 |
| HCC | Device, Biofeedback | 1 | 1 |
| JPK | Mixture, Hematology Quality Control | 1 | 1 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 | 1 |
Review panels
- Microbiology (3)
- Hematology (1)
- Neurology (1)
Most recent Intercare Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941938 | THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE | HCC | 1994-08-05 | 106 |
| K920569 | INDXTM DIP-S-TICKSTM | LSQ | 1993-02-09 | 368 |
| K901597 | INDX DIP S TICKS | LSQ | 1990-12-21 | 260 |
| K893895 | HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL | JPK | 1989-07-25 | 56 |
| K862948 | CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) | LJC | 1986-10-17 | 73 |
Recalls
openFDA lists no recalls under a recalling firm named Intercare Diagnostics, Inc..
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 Intercare Diagnostics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Intercare Diagnostics, Inc.” (first 1986, latest 1994), across 4 product codes in 3 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 Intercare Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intercare Diagnostics, Inc. is 106 days.
Which FDA product codes appear under Intercare Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are LSQ (Reagent, Rickettsia Serological, 2); HCC (Device, Biofeedback, 1); JPK (Mixture, Hematology Quality Control, 1).
Next steps
- See all 5 Intercare Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LSQ, Intercare Diagnostics, Inc.'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.