The following data is part of a premarket notification filed by Dako Corp. with the FDA for Staining System For Pneumocystis Carinii.
| Device ID | K905504 |
| 510k Number | K905504 |
| Device Name: | STAINING SYSTEM FOR PNEUMOCYSTIS CARINII |
| Classification | Pneumocystis Carinii |
| Applicant | DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Debora D Hinman |
| Correspondent | Debora D Hinman DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
| Product Code | LYF |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-07 |
| Decision Date | 1991-06-28 |