Submission Details
| 510(k) Number | K091980 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 2009 |
| Decision Date | September 22, 2009 |
| Days to Decision | 83 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Special
ACL TOP 700 LAS
Sep 2009
Decision
83d
Days
Class 2
Risk
About This 510(k) Submission
K091980 is an FDA 510(k) clearance for the ACL TOP 700 LAS, a Instrument, Coagulation, Automated (Class II — Special Controls, product code GKP), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on September 22, 2009, 83 days after receiving the submission on July 1, 2009. 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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