The following data is part of a premarket notification filed by Schiff & Co. with the FDA for Fastec 901 Agglutination Pattern Reader.
| Device ID | K895967 |
| 510k Number | K895967 |
| Device Name: | FASTEC 901 AGGLUTINATION PATTERN READER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| 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 | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-12 |
| Decision Date | 1989-10-30 |