Icl Scientific: FDA clearances and approvals
Icl Scientific has 48 FDA 510(k) clearances (first 1976, latest 1988), across 36 product codes in 6 review panels. Median 510(k) review time: 28 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 |
|---|---|---|---|
| DEW | Igg, Antigen, Antiserum, Control | 4 | 4 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 3 | 3 |
| CZP | Iga, Antigen, Antiserum, Control | 2 | 2 |
| DAK | Complement C1q, Antigen, Antiserum, Control | 2 | 2 |
| DEH | Lambda, Antigen, Antiserum, Control | 2 | 2 |
| DFH | Kappa, Antigen, Antiserum, Control | 2 | 2 |
| DFT | Igm, Antigen, Antiserum, Control | 2 | 2 |
| DHC | System, Test, Systemic Lupus Erythematosus | 2 | 2 |
| DIF | Drug Mixture Control Materials | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
Plus 26 more product codes.
Review panels
- Immunology (27)
- Clinical Chemistry (12)
- Clinical Toxicology (5)
- Gastroenterology and Urology (1)
- Hematology (1)
- Microbiology (1)
Most recent Icl Scientific 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883942 | HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL | JJY | 1988-11-10 | 52 |
| K843565 | KOVA TROL I,II, III HUMAN URINE-DRIED | JJW | 1984-10-05 | 25 |
| K833761 | THERAPEUTIC DRUG CONTROL | DKB | 1984-01-13 | 79 |
| K832823 | ENZYMUNE-TEST TSH | JLW | 1983-10-14 | 56 |
| K831383 | EVENT-TEST SLIDE | JHJ | 1983-06-22 | 55 |
| K823199 | ENZYME-TEST DIGOXIN | KXT | 1982-11-29 | 34 |
| K822777 | THERAPEUTIC DRUG CONTROL | DIF | 1982-10-08 | 24 |
| K822346 | HISTIMUNE ENZYME-ANA TEST | LJM | 1982-10-08 | 63 |
| K822465 | ENZYMUNE SYSTEM I | JJE | 1982-09-14 | 29 |
| K821374 | ENZYMUNE-TEST INSULIN | CFP | 1982-05-28 | 18 |
38 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Icl Scientific.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Icl Scientific's product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Icl Scientific have?
Icl Scientific has 48 FDA 510(k) clearances (first 1976, latest 1988), across 36 product codes in 6 review panels.
How long does FDA take to clear Icl Scientific's 510(k)s?
The median time from FDA receipt to decision across Icl Scientific's cleared 510(k)s is 28 days.
What devices does Icl Scientific make?
Its most frequent FDA product codes are DEW (Igg, Antigen, Antiserum, Control, 4); JJW (Urinalysis Controls (Assayed And Unassayed), 3); CZP (Iga, Antigen, Antiserum, Control, 2).
Has Icl Scientific had device recalls?
openFDA lists no recalls under a recalling firm name matching Icl Scientific. Related entities may recall under other names.
Next steps
- See all 48 Icl Scientific clearances with predicates and recalls
- Run predicate analysis for product code DEW, Icl Scientific'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.