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 |