The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hichem Alp/amp Reagent Kit.
| Device ID | K963383 |
| 510k Number | K963383 |
| Device Name: | HICHEM ALP/AMP REAGENT KIT |
| Classification | Phenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | HICHEM DIAGNOSTICS 231 NORTH PUENTE ST. Brea, CA 92821 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking HICHEM DIAGNOSTICS 231 NORTH PUENTE ST. Brea, CA 92821 |
| Product Code | CKF |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-27 |
| Decision Date | 1996-09-23 |
| Summary: | summary |