The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Fe-cult Plus.
| Device ID | K820072 |
| 510k Number | K820072 |
| Device Name: | FE-CULT PLUS |
| Classification | Reagent, Occult Blood |
| Applicant | GAMMA BIOLOGICALS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-12 |
| Decision Date | 1982-03-04 |