Kenlor Industries, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Kenlor Industries, Inc.” (first 1989, latest 1997), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 | 3 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 2 | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | 1 | 1 |
| LYR | Helicobacter Pylori | 1 | 1 |
Review panels
- Clinical Chemistry (8)
- Microbiology (1)
Most recent Kenlor Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964014 | KENLOR H. PYLORI CONTROL SERUM | LYR | 1997-03-03 | 147 |
| K952840 | KENLOR LIQUID TOTAL URINE CONTROL | JJW | 1995-07-19 | 28 |
| K950326 | KENLOR HUMAN SPINAL FLUID CONTROL | JJY | 1995-03-20 | 61 |
| K903338 | KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL | JJY | 1990-09-07 | 44 |
| K896440 | KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT | JIR | 1990-02-16 | 99 |
| K890618 | COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT | CEK | 1989-05-22 | 104 |
| K890573 | KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT | JIY | 1989-03-24 | 46 |
| K890577 | KENLOR LIQUID URINE CONTROL | JJW | 1989-03-09 | 31 |
| K890576 | KENLOR HUMAN SPINAL FLUID CONTROL LIQUID | JJY | 1989-03-09 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Kenlor Industries, 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 Kenlor Industries, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Kenlor Industries, Inc.” (first 1989, latest 1997), across 6 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 Kenlor Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kenlor Industries, Inc. is 46 days.
Which FDA product codes appear under Kenlor Industries, Inc.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 3); JJW (Urinalysis Controls (Assayed And Unassayed), 2); CEK (Biuret (Colorimetric), Total Protein, 1).
Next steps
- See all 9 Kenlor Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Kenlor Industries, 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.