The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Ion 2/4 Flow Cell Cleaner (product #88656).
| Device ID | K863617 |
| 510k Number | K863617 |
| Device Name: | ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea, CA 92621 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea, CA 92621 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-16 |
| Decision Date | 1986-10-24 |