The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Hi Chem Total Protein/albumin Serum Range Lin Stnd.
| Device ID | K902673 |
| 510k Number | K902673 |
| Device Name: | HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea, CA 92621 |
| Contact | Bentley Tam |
| Correspondent | Bentley Tam HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea, CA 92621 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-18 |
| Decision Date | 1990-07-17 |