Instrumentation Laboratory (IL) Co.: FDA clearances and approvals
Instrumentation Laboratory (IL) Co. has 5 FDA 510(k) clearances (first 2024, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time: 30 days. Since 2017 its median was 30 days, against 51 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 28 |
| 2025 | 2 | 59 |
| 2026 | 2 | 30 |
Review time against the same product codes
Since 2017, Instrumentation Laboratory (IL) Co.'s cleared 510(k)s took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 51 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GFO | Activated Partial Thromboplastin | 1 | 1 |
| GGW | Test, Time, Partial Thromboplastin | 1 | 1 |
| GKP | Instrument, Coagulation, Automated | 1 | 1 |
| KQJ | System, Fibrinogen Determination | 1 | 1 |
| LCO | Platelet Factor 4 Radioimmunoassay | 1 | 1 |
Review panels
- Hematology (5)
Most recent Instrumentation Laboratory (IL) Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260551 | HemosIL Factor V Leiden (APC Resistance V) | GGW | 2026-03-20 | 30 |
| K253957 | HemosIL Silica Clotting Time | GFO | 2026-01-09 | 30 |
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | KQJ | 2025-07-24 | 28 |
| K243374 | HemosIL CL HIT-IgG(PF4-H) | LCO | 2025-01-28 | 90 |
| K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) | GKP | 2024-08-16 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Instrumentation Laboratory (IL) Co..
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 Instrumentation Laboratory (IL) Co. have?
Instrumentation Laboratory (IL) Co. has 5 FDA 510(k) clearances (first 2024, latest 2026), across 5 product codes in 1 review panel.
How long does FDA take to clear Instrumentation Laboratory (IL) Co.'s 510(k)s?
The median time from FDA receipt to decision across Instrumentation Laboratory (IL) Co.'s cleared 510(k)s is 30 days. Since 2017: 30 days, versus 51 days for all cleared 510(k)s in the same product codes.
What devices does Instrumentation Laboratory (IL) Co. make?
Its most frequent FDA product codes are GFO (Activated Partial Thromboplastin, 1); GGW (Test, Time, Partial Thromboplastin, 1); GKP (Instrument, Coagulation, Automated, 1).
Has Instrumentation Laboratory (IL) Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Instrumentation Laboratory (IL) Co. Related entities may recall under other names.
Next steps
- See all 5 Instrumentation Laboratory (IL) Co. clearances with predicates and recalls
- Run predicate analysis for product code GFO, Instrumentation Laboratory (IL) Co.'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.