Solarcare Technologies Corp,Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Solarcare Technologies Corp,Inc.” (first 1991, latest 1996), across 18 product codes in 4 review panels. Median 510(k) review time under this name: 120 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 3 | 3 |
| DKZ | Enzyme Immunoassay, Amphetamine | 3 | 3 |
| GEH | Unit, Cryosurgical, Accessories | 3 | 3 |
| JXO | Enzyme Immunoassay, Cocaine | 2 | 2 |
| KQO | Automated Urinalysis System | 2 | 2 |
| LCM | Enzyme Immunoassay, Phencyclidine | 2 | 2 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 2 | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
Plus 8 more product codes.
Review panels
- Clinical Toxicology (17)
- Clinical Chemistry (7)
- General and Plastic Surgery (3)
- Ear, Nose and Throat (1)
Most recent Solarcare Technologies Corp,Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954326 | STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY | JIT | 1996-07-23 | 312 |
| K954156 | STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY | KQO | 1996-07-22 | 321 |
| K955905 | STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY | CEK | 1996-05-30 | 153 |
| K954158 | STC DIAGNOSTICS AUTO-LYTE PH ASSAY | KQO | 1996-04-30 | 238 |
| K940048 | STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION | DLJ | 1996-03-19 | 804 |
| K954073 | STC DIAGNOSTICS LSD MICRO-PLATE EIA | DLB | 1995-11-29 | 91 |
| K954266 | STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY | CGX | 1995-10-13 | 31 |
| K935573 | AMPHETAMINES MICRO-PLATE EIA | DKZ | 1995-07-14 | 603 |
| K935565 | OPIATES MICRO-PLATE ASSAY | DJG | 1995-07-14 | 603 |
| K950308 | STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA | JXS | 1995-04-14 | 79 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Solarcare Technologies Corp,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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Solarcare, Inc. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Solarcare Technologies Corp,Inc.?
FDA lists 28 510(k) clearances under the applicant name “Solarcare Technologies Corp,Inc.” (first 1991, latest 1996), across 18 product codes in 4 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 Solarcare Technologies Corp,Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Solarcare Technologies Corp,Inc. is 120 days.
Which FDA product codes appear under Solarcare Technologies Corp,Inc.?
The most frequent FDA product codes under this applicant name are DJG (Enzyme Immunoassay, Opiates, 3); DKZ (Enzyme Immunoassay, Amphetamine, 3); GEH (Unit, Cryosurgical, Accessories, 3).
Next steps
- See all 28 Solarcare Technologies Corp,Inc. clearances with predicates and recalls
- Run predicate analysis for product code DJG, Solarcare Technologies Corp,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, 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.