The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Hemawipe System, The Civilized Test.
| Device ID | K884206 |
| 510k Number | K884206 |
| Device Name: | HEMAWIPE SYSTEM, THE CIVILIZED TEST |
| Classification | Reagent, Occult Blood |
| Applicant | LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Contact | Lora Jones |
| Correspondent | Lora Jones LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-06 |
| Decision Date | 1989-04-18 |