The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Systems Cholesterol (chol) Reagent.
| Device ID | K971505 |
| 510k Number | K971505 |
| Device Name: | SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Contact | Sheri Hall |
| Correspondent | Sheri Hall BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-25 |
| Decision Date | 1997-06-11 |
| Summary: | summary |