The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Hi Chem Diagnostics Ldl Reagent Cartridge.
| Device ID | K861419 |
| 510k Number | K861419 |
| Device Name: | HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea, CA 92621 |
| Contact | Andrew J Estrada |
| Correspondent | Andrew J Estrada HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea, CA 92621 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-15 |
| Decision Date | 1986-04-28 |