The following data is part of a premarket notification filed by Harleco with the FDA for Histochemical Afb Demonstration.
| Device ID | K771390 |
| 510k Number | K771390 |
| Device Name: | HISTOCHEMICAL AFB DEMONSTRATION |
| Classification | Carbol Fuchsin |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ICL |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-07-27 |
| Decision Date | 1977-08-22 |