The following data is part of a premarket notification filed by Enzo Biochem, Inc. with the FDA for Hemagel(tm) Test For Fecal Occult Blood.
| Device ID | K881907 |
| 510k Number | K881907 |
| Device Name: | HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD |
| Classification | Reagent, Occult Blood |
| Applicant | ENZO BIOCHEM, INC. 325 HUDSON ST. New York, NY 10013 |
| Contact | J Olsiewski |
| Correspondent | J Olsiewski ENZO BIOCHEM, INC. 325 HUDSON ST. New York, NY 10013 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-06 |
| Decision Date | 1988-07-08 |