The following data is part of a premarket notification filed by Schiff & Co. with the FDA for Olympus Pk-tp System Reactive Control.
| Device ID | K894617 |
| 510k Number | K894617 |
| Device Name: | OLYMPUS PK-TP SYSTEM REACTIVE CONTROL |
| Classification | Antigen, Cf And / Or Id, Coccidioides Immitis |
| 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 | GMI |
| CFR Regulation Number | 866.3135 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-10-31 |