The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Clinalyzer Model Vx-1000.
| Device ID | K851638 |
| 510k Number | K851638 |
| Device Name: | CLINALYZER MODEL VX-1000 |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | ALPKEM CORP. BOX 1260 Clackamas, OR 97015 |
| Contact | William H Souder |
| Correspondent | William H Souder ALPKEM CORP. BOX 1260 Clackamas, OR 97015 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-19 |
| Decision Date | 1985-05-13 |