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 |