The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Freshcells.
Device ID | K972414 |
510k Number | K972414 |
Device Name: | FRESHCELLS |
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 | 1997-06-27 |
Decision Date | 1997-08-29 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FRESHCELLS 76160334 not registered Dead/Abandoned |
Diagnostic Hybrids, Inc. 2000-11-06 |