The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Saitron 430 Random Access Chemistry Analyzer.
| Device ID | K884035 |
| 510k Number | K884035 |
| Device Name: | SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Contact | King, Ph.d. |
| Correspondent | King, Ph.d. SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-23 |
| Decision Date | 1988-12-29 |