The following data is part of a premarket notification filed by Labsystems, Inc. with the FDA for Resubmitted Fecatwin Sensitive - Feca-eia.
| Device ID | K896474 |
| 510k Number | K896474 |
| Device Name: | RESUBMITTED FECATWIN SENSITIVE - FECA-EIA |
| Classification | Reagent, Occult Blood |
| Applicant | LABSYSTEMS, INC. PULTTITIE 8 00880 HELSINKI Finland, FI |
| Contact | Paivi Sormunen |
| Correspondent | Paivi Sormunen LABSYSTEMS, INC. PULTTITIE 8 00880 HELSINKI Finland, FI |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-13 |
| Decision Date | 1990-01-25 |