Submission Details
| 510(k) Number | K231031 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 11, 2023 |
| Decision Date | June 21, 2023 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
ACL TOP Family 70 Series
Jun 2023
Decision
71d
Days
Class 2
Risk
About This 510(k) Submission
K231031 is an FDA 510(k) clearance for the ACL TOP Family 70 Series, a Instrument, Coagulation, Automated (Class II — Special Controls, product code GKP), submitted by Instrumentation Laboratory Company (Bedford, US). The FDA issued a Cleared decision on June 21, 2023, 71 days after receiving the submission on April 11, 2023. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.
Device Classification
| Product Code | GKP — Instrument, Coagulation, Automated |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.5400 |
Manufacturer
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