The following data is part of a premarket notification filed by Carr-scarborough Microbiologicals, Inc. with the FDA for C. Albicans Screen.
| Device ID | K891476 |
| 510k Number | K891476 |
| Device Name: | C. ALBICANS SCREEN |
| Classification | Kit, Screening, Yeast |
| Applicant | CARR-SCARBOROUGH MICROBIOLOGICALS, INC. P.O. BOX 1328 Stone Mountain, GA 30086 |
| Contact | C Scarborough |
| Correspondent | C Scarborough CARR-SCARBOROUGH MICROBIOLOGICALS, INC. P.O. BOX 1328 Stone Mountain, GA 30086 |
| Product Code | JXC |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-16 |
| Decision Date | 1989-04-12 |