The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Test Dat Cal/control Set D/e.
| Device ID | K920419 |
| 510k Number | K920419 |
| Device Name: | IL TEST DAT CAL/CONTROL SET D/E |
| Classification | Coating, Liquid, Glc |
| Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. P.O. BOX 9113 Lexington, MA 02173 |
| Contact | Gabriel J Muraca |
| Correspondent | Gabriel J Muraca INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. P.O. BOX 9113 Lexington, MA 02173 |
| Product Code | DLG |
| CFR Regulation Number | 862.2250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-31 |
| Decision Date | 1992-03-11 |