The following data is part of a premarket notification filed by Schiff & Co. with the FDA for Cleantech System.
| Device ID | K882539 |
| 510k Number | K882539 |
| Device Name: | CLEANTECH SYSTEM |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-21 |
| Decision Date | 1988-08-08 |