The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Freshcells, Hep-2.
| Device ID | K962780 |
| 510k Number | K962780 |
| Device Name: | FRESHCELLS, HEP-2 |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | DIAGNOSTIC HYBRIDS, INC. ONE PRESIDENT ST. Athens, OH 45701 |
| Contact | James L Brown |
| Correspondent | James L Brown DIAGNOSTIC HYBRIDS, INC. ONE PRESIDENT ST. Athens, OH 45701 |
| Product Code | KIR |
| CFR Regulation Number | 864.2280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-17 |
| Decision Date | 1996-08-29 |
| Summary: | summary |