The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Test Lac Screen (claims Added To Acl Futura), Il Test Lac Confirm (claims Addad To Acl Futura).
| Device ID | K990302 |
| 510k Number | K990302 |
| Device Name: | IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) |
| Classification | Reagent, Russel Viper Venom |
| Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | GIR |
| CFR Regulation Number | 864.8950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-01 |
| Decision Date | 1999-04-08 |
| Summary: | summary |