The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Hichem Calcium Reagent For The Synchron Cx3 Prod. No. 88808.
| Device ID | K941764 |
| 510k Number | K941764 |
| Device Name: | HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 |
| Classification | Azo Dye, Calcium |
| 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 | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-29 |
| Decision Date | 1994-05-13 |