The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Assure Level I Prod. #30171.
| Device ID | K801538 |
| 510k Number | K801538 |
| Device Name: | ASSURE LEVEL I PROD. #30171 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | WARNER-LAMBERT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-03 |
| Decision Date | 1980-09-09 |