The following data is part of a premarket notification filed by Devetec, Inc. with the FDA for Tif Fecal Test.
| Device ID | K873594 |
| 510k Number | K873594 |
| Device Name: | TIF FECAL TEST |
| Classification | Preservative, Cytological |
| Applicant | DEVETEC, INC. P.O. BOX 10275 Bradenton, FL 34282 -0275 |
| Contact | Price, Phd |
| Correspondent | Price, Phd DEVETEC, INC. P.O. BOX 10275 Bradenton, FL 34282 -0275 |
| Product Code | LEA |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-04 |
| Decision Date | 1987-09-29 |