Sandare Chemical Co., Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Sandare Chemical Co., Inc.” (first 1979, latest 1987), across 19 product codes in 2 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | 4 | 4 |
| JPK | Mixture, Hematology Quality Control | 2 | 2 |
| CED | 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| CIO | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
Plus 9 more product codes.
Review panels
- Clinical Chemistry (15)
- Hematology (8)
Most recent Sandare Chemical Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K872852 | EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST | LCP | 1987-09-29 | 71 |
| K862556 | SANDARE GLYCOHEMOGLOBIN PROCEDURE | LCP | 1986-08-08 | 36 |
| K860684 | SANDARE BCG ALBUMIN PROCEDURE | CIX | 1986-03-17 | 20 |
| K851395 | SANDARE IRON-BINDING CAPACITY PROCEDURE | JMO | 1985-05-07 | 28 |
| K851394 | SANDARE IRON PROCEDURE | JIY | 1985-04-30 | 21 |
| K844498 | SANDARE ALKALINE PHOSPHATASE PROCEDURE | CIO | 1984-12-10 | 20 |
| K842516 | SANDARE ACID PHOSPHATASE PROCEDURE | CJR | 1984-08-17 | 38 |
| K833898 | TRI-LEVEL BILIRUBIN CONTROLS | JJX | 1984-01-13 | 60 |
| K832942 | TOTAL & DIRECT BILIRUBIN PROCEDURES | CIG | 1983-11-07 | 69 |
| K832632 | ALBUMIN PROCEDURE BCP | CJW | 1983-09-12 | 39 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sandare Chemical Co., 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 Sandare Chemical Co., Inc.?
FDA lists 23 510(k) clearances under the applicant name “Sandare Chemical Co., Inc.” (first 1979, latest 1987), across 19 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 Sandare Chemical Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sandare Chemical Co., Inc. is 32 days.
Which FDA product codes appear under Sandare Chemical Co., Inc.?
The most frequent FDA product codes under this applicant name are LCP (Assay, Glycosylated Hemoglobin, 4); JPK (Mixture, Hematology Quality Control, 2); CED (5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase, 1).
Next steps
- See all 23 Sandare Chemical Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code LCP, Sandare Chemical Co., 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.