Harleco Diagnostics: FDA clearances and approvals
Harleco Diagnostics has 23 FDA 510(k) clearances (first 1976, latest 1982), across 20 product codes in 1 review panel. Median 510(k) review time: 19 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 |
|---|---|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 | 2 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 | 2 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CEX | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
Plus 10 more product codes.
Review panels
- Clinical Chemistry (23)
Most recent Harleco Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823147 | URIC ACID STANDARD, 8MG/DL #65078 | JIS | 1982-11-22 | 28 |
| K822852 | TRIGLYCERIDE CALIBRATOR | JIT | 1982-10-27 | 33 |
| K822323 | ULTRACHEM BUN-UV, 65080 & 65081 | CDW | 1982-09-02 | 30 |
| K821883 | ULTRAZYME PLUS CK-I | CGS | 1982-07-14 | 19 |
| K821882 | ULTRAZYME PLUS GPT | CKA | 1982-07-14 | 19 |
| K821881 | ULTRACHEM CREA | CGX | 1982-07-14 | 19 |
| K821880 | ULTRA CHEM ALB | CIX | 1982-07-14 | 19 |
| K821879 | ULTRACHEM T.P. | CEX | 1982-07-14 | 19 |
| K821878 | ULTRAZYME PLUS LDH | CFJ | 1982-07-14 | 19 |
| K821877 | ULTRAZYME PLUS HBD | JMK | 1982-07-14 | 19 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Harleco Diagnostics.
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 Diagnostics have?
Harleco Diagnostics has 23 FDA 510(k) clearances (first 1976, latest 1982), across 20 product codes in 1 review panel.
How long does FDA take to clear Harleco Diagnostics's 510(k)s?
The median time from FDA receipt to decision across Harleco Diagnostics's cleared 510(k)s is 19 days.
What devices does Harleco Diagnostics make?
Its most frequent FDA product codes are CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, 2); CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes, 2); CIX (Bromcresol Green Dye-Binding, Albumin, 2).
Has Harleco Diagnostics had device recalls?
openFDA lists no recalls under a recalling firm name matching Harleco Diagnostics. Related entities may recall under other names.
Next steps
- See all 23 Harleco Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code CFJ, Harleco Diagnostics'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.