The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Normal And Abnormal Control Sera.
| Device ID | K895943 |
| 510k Number | K895943 |
| Device Name: | NORMAL AND ABNORMAL CONTROL SERA |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-11 |
| Decision Date | 1989-12-27 |