The following data is part of a premarket notification filed by U. S. Diagnostics, Inc. with the FDA for U.s. Diagnostics Serum Cholesterol Test.
| Device ID | K864081 |
| 510k Number | K864081 |
| Device Name: | U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo, CA 93401 |
| Contact | Roy E Speck |
| Correspondent | Roy E Speck U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo, CA 93401 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-20 |
| Decision Date | 1986-12-04 |