The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Single (specified) Analyte Control (assayed).
| Device ID | K894804 |
| 510k Number | K894804 |
| Device Name: | SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED) |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | LIFESCAN, INC. 2443 WYANDOTTE ST. Mountain View, CA 94043 |
| Contact | Rosemary D Self |
| Correspondent | Rosemary D Self LIFESCAN, INC. 2443 WYANDOTTE ST. Mountain View, CA 94043 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-28 |
| Decision Date | 1989-09-28 |