The following data is part of a premarket notification filed by Jrga Diagnostics with the FDA for Albicans Sure.
Device ID | K913426 |
510k Number | K913426 |
Device Name: | ALBICANS SURE |
Classification | Kit, Screening, Yeast |
Applicant | JRGA DIAGNOSTICS J.R. GREENWOOD AND ASSOCIATES 27481 SILVER CREEK DRIVE San Juan Capistrano, CA 92675 |
Contact | James R Greenwood |
Correspondent | James R Greenwood JRGA DIAGNOSTICS J.R. GREENWOOD AND ASSOCIATES 27481 SILVER CREEK DRIVE San Juan Capistrano, CA 92675 |
Product Code | JXC |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-01 |
Decision Date | 1992-04-22 |