The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hichem Ldh/l Reagent Kit.
| Device ID | K946022 |
| 510k Number | K946022 |
| Device Name: | HICHEM LDH/L REAGENT KIT |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| 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 | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-12 |
| Decision Date | 1995-02-23 |