Pierce Chemical Co.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Pierce Chemical Co.” (first 1978, latest 1989), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| JGY | Colorimetric Method, Triglycerides | 1 | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 | 1 |
Review panels
- Clinical Chemistry (6)
- Hematology (4)
Most recent Pierce Chemical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K895661 | GLYCOTEST II GLYHB ASSAY KIT | LCP | 1989-12-07 | 78 |
| K831837 | CLINOVATIVE II DIAGNOSTIC KIT | LCP | 1983-08-01 | 55 |
| K821360 | GLYCO-GEL TEST KIT | LCP | 1982-06-02 | 26 |
| K820279 | GLYCO-GEL TEST KIT | LCP | 1982-04-08 | 65 |
| K781897 | STAT KIT, MICROPROTEIN | CEK | 1979-01-10 | 58 |
| K780827 | URIC ACID RAPID STAT KIT | KNK | 1978-06-13 | 25 |
| K780826 | BILIRUBIN RAPID STAT KIT | CIG | 1978-05-26 | 7 |
| K780825 | TRIGLYCERIDE C-37 RAPID STAT KIT | JGY | 1978-05-26 | 7 |
| K780512 | AUTO/STAT KIT | CGA | 1978-05-03 | 34 |
| K780331 | CHOLESTEROL RAPID SLAT KIT HDL | CHH | 1978-04-06 | 37 |
Recalls
openFDA lists no recalls under a recalling firm named Pierce Chemical Co..
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.
- Pierce Biotechnology, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pierce Chemical Co.?
FDA lists 10 510(k) clearances under the applicant name “Pierce Chemical Co.” (first 1978, latest 1989), across 7 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 Pierce Chemical Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pierce Chemical Co. is 36 days.
Which FDA product codes appear under Pierce Chemical Co.?
The most frequent FDA product codes under this applicant name are LCP (Assay, Glycosylated Hemoglobin, 4); CEK (Biuret (Colorimetric), Total Protein, 1); CGA (Glucose Oxidase, Glucose, 1).
Next steps
- See all 10 Pierce Chemical Co. clearances with predicates and recalls
- Run predicate analysis for product code LCP, Pierce Chemical Co.'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.