The following data is part of a premarket notification filed by Diagnostic Markers, Inc. with the FDA for Yeastest.
| Device ID | K993554 |
| 510k Number | K993554 |
| Device Name: | YEASTEST |
| Classification | Kit, Identification, Yeast |
| Applicant | DIAGNOSTIC MARKERS, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland DIAGNOSTIC MARKERS, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | JXB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 1999-10-20 |
| Decision Date | 2000-02-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() YEASTEST 74153611 not registered Dead/Abandoned |
Diagnostic Markers, Incorporated 1991-04-03 |