The following data is part of a premarket notification filed by Med Tech Products, Inc. with the FDA for Access Digiwipe System.
| Device ID | K853141 |
| 510k Number | K853141 |
| Device Name: | ACCESS DIGIWIPE SYSTEM |
| Classification | Reagent, Occult Blood |
| Applicant | MED TECH PRODUCTS, INC. 16101 NORTH WEST 57TH. AVE. Miami, FL 33014 |
| Contact | Bruce A Clinton |
| Correspondent | Bruce A Clinton MED TECH PRODUCTS, INC. 16101 NORTH WEST 57TH. AVE. Miami, FL 33014 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-24 |
| Decision Date | 1985-11-18 |