The following data is part of a premarket notification filed by Cooper Biomedical, Inc. with the FDA for Ion Selective Electrode.
| Device ID | K841076 |
| 510k Number | K841076 |
| Device Name: | ION SELECTIVE ELECTRODE |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | COOPER BIOMEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-12 |
| Decision Date | 1984-05-07 |