The following data is part of a premarket notification filed by Medi-tech, Inc. with the FDA for Pf Test.
| Device ID | K884513 |
| 510k Number | K884513 |
| Device Name: | PF TEST |
| Classification | Antigens, All Types, Escherichia Coli |
| Applicant | MEDI-TECH, INC. 71 VERONICA AVE. P.O. BOX 218 Somerset, NJ 08873 |
| Contact | Julie Demarco |
| Correspondent | Julie Demarco MEDI-TECH, INC. 71 VERONICA AVE. P.O. BOX 218 Somerset, NJ 08873 |
| Product Code | GMZ |
| CFR Regulation Number | 866.3255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-27 |
| Decision Date | 1989-02-03 |