K990302 is an FDA 510(k) clearance for the IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA). This device is classified as a Reagent, Russel Viper Venom (Class I - General Controls, product code GIR).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on April 8, 1999, 66 days after receiving the submission on February 1, 1999.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8950.
| 510(k) Number | K990302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1999 |
| Decision Date | April 08, 1999 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GIR — Reagent, Russel Viper Venom |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.8950 |