Harleco: FDA clearances and approvals
Harleco has 116 FDA 510(k) clearances (first 1976, latest 1982), across 41 product codes in 3 review panels. Median 510(k) review time: 25 days.
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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 8 | 8 |
| CEK | Biuret (Colorimetric), Total Protein | 6 | 6 |
| CFR | Hexokinase, Glucose | 6 | 6 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 6 | 6 |
| CIG | Diazo Colorimetry, Bilirubin | 6 | 6 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 5 | 5 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 5 | 5 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 5 | 5 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 4 | 4 |
| CIJ | Saccharogenic, Amylase | 4 | 4 |
Plus 31 more product codes.
Review panels
- Clinical Chemistry (101)
- Pathology (6)
- Hematology (4)
Most recent Harleco 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K820233 | ULTRAZYME PLUS GAMMA GT(65055-65056) | JQB | 1982-02-12 | 15 |
| K813427 | ULTRACHEM GLUC-DH | LFR | 1981-12-31 | 24 |
| K813044 | ULTRACHEM ALB, ITEM #64970 | CIX | 1981-11-10 | 13 |
| K813043 | ULTRACHEM CREA ITEM #64972 | CGX | 1981-11-10 | 13 |
| K813042 | ULTRACHEM GLUC-DH SET, ITEM #65048 | LFR | 1981-11-10 | 13 |
| K813041 | ULTRAZYME-GT, ITEM #64959 & 65032 | JQB | 1981-11-10 | 13 |
| K813040 | ULTRACHEM CA, ITEM #64975 | CJY | 1981-11-10 | 13 |
| K813039 | ULTRACHEM E-CHOL, ITEM #65025 | CHH | 1981-11-10 | 13 |
| K813038 | ULTRACHEM TP, ITEM #64974 | CEK | 1981-11-10 | 13 |
| K812594 | ULTRA ZYME PLUS AMYL #64982 & 65031 | CIJ | 1981-10-02 | 21 |
106 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Harleco.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Harleco have?
Harleco has 116 FDA 510(k) clearances (first 1976, latest 1982), across 41 product codes in 3 review panels.
How long does FDA take to clear Harleco's 510(k)s?
The median time from FDA receipt to decision across Harleco's cleared 510(k)s is 25 days.
What devices does Harleco make?
Its most frequent FDA product codes are CGX (Alkaline Picrate, Colorimetry, Creatinine, 8); CEK (Biuret (Colorimetric), Total Protein, 6); CFR (Hexokinase, Glucose, 6).
Has Harleco had device recalls?
openFDA lists no recalls under a recalling firm name matching Harleco. Related entities may recall under other names.
Next steps
- See all 116 Harleco clearances with predicates and recalls
- Run predicate analysis for product code CGX, Harleco's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.