The following data is part of a premarket notification filed by Select Medical Systems, Inc. with the FDA for Selecta 20/60 Chemistry Analyzer.
| Device ID | K942922 |
| 510k Number | K942922 |
| Device Name: | SELECTA 20/60 CHEMISTRY ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | SELECT MEDICAL SYSTEMS, INC. 4001 RIVER VIEW DR. Birmingham, AL 35243 |
| Contact | Sherry L Myers |
| Correspondent | Sherry L Myers SELECT MEDICAL SYSTEMS, INC. 4001 RIVER VIEW DR. Birmingham, AL 35243 |
| Product Code | JJE |
| Subsequent Product Code | CIX |
| Subsequent Product Code | CJE |
| Subsequent Product Code | JFJ |
| Subsequent Product Code | JHS |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-21 |
| Decision Date | 1995-07-19 |