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 |