The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Hi Chem Diagnostics Cleaning Neutralizer Sol#88193.
| Device ID | K853003 |
| 510k Number | K853003 |
| Device Name: | HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193 |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | HI CHEM, INC. P.O. BOX 1599 Brea, CA 92622 |
| Contact | Andrew J Estrada |
| Correspondent | Andrew J Estrada HI CHEM, INC. P.O. BOX 1599 Brea, CA 92622 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-16 |
| Decision Date | 1985-08-06 |