The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Freshfrozencells.
| Device ID | K962311 |
| 510k Number | K962311 |
| Device Name: | FRESHFROZENCELLS |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | DIAGNOSTIC HYBRIDS, INC. ONE PRESIDENT ST. Athens, OH 45701 |
| Contact | J.l. Brown |
| Correspondent | J.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 | 1996-06-17 |
| Decision Date | 1996-08-29 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FRESHFROZENCELLS 76160195 2901005 Live/Registered |
DIAGNOSTIC HYBRIDS, INC. 2000-11-06 |