The following data is part of a premarket notification filed by Diagnostica, Inc. with the FDA for Dermatophytin O.
Device ID | K790671 |
510k Number | K790671 |
Device Name: | DERMATOPHYTIN O |
Classification | Kit, Identification, Yeast |
Applicant | DIAGNOSTICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JXB |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-06 |
Decision Date | 1979-05-31 |