Instrumentation Laboratory CO: FDA clearances and approvals
Instrumentation Laboratory CO has 323 FDA 510(k) clearances (first 1976, latest 2023), plus 1 De Novo decision, across 139 product codes in 7 review panels. Median 510(k) review time: 62 days. Since 2017 its median was 61 days, against 199 days for all cleared 510(k)s in the same product codes. openFDA lists 104 product recalls by a recalling firm named Instrumentation Laboratory CO.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 137 |
| 2013 | 1 | 212 |
| 2014 | 4 | 157 |
| 2015 | 2 | 142 |
| 2016 | 9 | 252 |
| 2017 | 4 | 60 |
| 2018 | 1 | 27 |
| 2019 | 3 | 58 |
| 2020 | 1 | 225 |
| 2021 | 1 | 235 |
| 2022 | 3 | 299 |
| 2023 | 4 | 186 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Instrumentation Laboratory CO's cleared 510(k)s took a median 61 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 199 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 27 | 27 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 15 | 15 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 12 | 12 |
| GJS | Test, Time, Prothrombin | 11 | 11 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 10 | 10 |
| GJT | Plasma, Coagulation Factor Deficient | 10 | 10 |
| CGA | Glucose Oxidase, Glucose | 9 | 9 |
| JBQ | Antithrombin Iii Quantitation | 9 | 9 |
| GGN | Plasma, Coagulation Control | 8 | 8 |
| GKP | Instrument, Coagulation, Automated | 8 | 8 |
Plus 129 more product codes.
Review panels
- Hematology (127)
- Clinical Chemistry (112)
- Clinical Toxicology (35)
- Immunology (24)
- Cardiovascular (14)
- Anesthesiology (4)
- Microbiology (4)
Most recent Instrumentation Laboratory CO 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233790 | ACL TOP 970 CL | JPA | 2023-12-29 | 31 |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | JPA | 2023-09-29 | 506 |
| K223187 | HemosIL Liquid Anti-Xa | QLU | 2023-06-23 | 254 |
| K223090 | GEM Premier ChemSTAT | CGA | 2023-01-27 | 119 |
| K223402 | HemosIL von Willebrand Factor Antigen | GGP | 2022-12-09 | 30 |
| K213464 | HemosIL Liquid Anti-Xa | KFF | 2022-10-04 | 341 |
| K213426 | HemosIL ReadiPlasTin | GJS | 2022-08-16 | 299 |
| K203790 | GEM Premier 5000 | CHL | 2021-08-20 | 235 |
| K200033 | HemosIL von Willebrand Factor Antigen | GGP | 2020-08-19 | 225 |
| K183555 | GEM Premier ChemSTAT | JFY | 2019-02-16 | 58 |
313 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN190032 | De Novo | Anti-Factor Xa Activity Test System, Apixaban | 2020-09-17 |
Recalls
104 product recalls in 38 recall events; 43 initiated in the last five years. Most recent: 2026-05-21.
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 Instrumentation Laboratory CO's product codes (a text match, not an official crosswalk):
- J7197 — Antithrombin iii (human), per i.u. (via JBQ)
- J7213 — Injection, coagulation factor ix (recombinant), ixinity, 1 i.u. (via GJT)
Frequently asked questions
How many FDA 510(k) clearances does Instrumentation Laboratory CO have?
Instrumentation Laboratory CO has 323 FDA 510(k) clearances (first 1976, latest 2023), plus 1 De Novo decision, across 139 product codes in 7 review panels.
How long does FDA take to clear Instrumentation Laboratory CO's 510(k)s?
The median time from FDA receipt to decision across Instrumentation Laboratory CO's cleared 510(k)s is 62 days. Since 2017: 61 days, versus 199 days for all cleared 510(k)s in the same product codes.
What devices does Instrumentation Laboratory CO make?
Its most frequent FDA product codes are GGP (Test, Qualitative And Quantitative Factor Deficiency, 27); CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 15); JPA (System, Multipurpose For In Vitro Coagulation Studies, 12).
Has Instrumentation Laboratory CO had device recalls?
openFDA lists 104 product recalls in 38 recall events by a recalling firm whose name matches Instrumentation Laboratory CO; the most recent began 2026-05-21. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 323 Instrumentation Laboratory CO clearances with predicates and recalls
- Run predicate analysis for product code GGP, Instrumentation Laboratory 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.