The following data is part of a premarket notification filed by Cooper Biomedical, Inc. with the FDA for Assist Clinical Chemistry Analyzer.
| Device ID | K852262 |
| 510k Number | K852262 |
| Device Name: | ASSIST CLINICAL CHEMISTRY ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | COOPER BIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Contact | Daniel, Ph.d. |
| Correspondent | Daniel, Ph.d. COOPER BIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-24 |
| Decision Date | 1985-06-25 |