The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Multiconstituent Serum Range Linearity #88234.
| Device ID | K901115 |
| 510k Number | K901115 |
| Device Name: | MULTICONSTITUENT SERUM RANGE LINEARITY #88234 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Contact | Bentley Tam |
| Correspondent | Bentley Tam HICHEM DIAGNOSTICS 231 N. PUENTE ST. 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 | 1990-03-09 |
| Decision Date | 1990-04-19 |