The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for (skd) Cholesterol Test Kit.
| Device ID | K875131 |
| 510k Number | K875131 |
| Device Name: | (SKD) CHOLESTEROL TEST KIT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 485 POTRERO AVE. P.O. BOX 61947 Sunnyvale, CA 94086 |
| Contact | Christopher Zalesky |
| Correspondent | Christopher Zalesky SMITH KLINE DIAGNOSTICS, INC. 485 POTRERO AVE. P.O. BOX 61947 Sunnyvale, CA 94086 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-15 |
| Decision Date | 1988-03-01 |