STAINING SYSTEM FOR PNEUMOCYSTIS CARINII

Pneumocystis Carinii

DAKO CORP.

The following data is part of a premarket notification filed by Dako Corp. with the FDA for Staining System For Pneumocystis Carinii.

Pre-market Notification Details

Device IDK905504
510k NumberK905504
Device Name:STAINING SYSTEM FOR PNEUMOCYSTIS CARINII
ClassificationPneumocystis Carinii
Applicant DAKO CORP. 6392 VIA REAL Carpinteria,  CA  93013
ContactDebora D Hinman
CorrespondentDebora D Hinman
DAKO CORP. 6392 VIA REAL Carpinteria,  CA  93013
Product CodeLYF  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-07
Decision Date1991-06-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.