PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT

Pneumocystis Carinii

GENETIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Genetic Systems Corp. with the FDA for Pneumocystis Carinii Immunofluorescence Test Kit.

Pre-market Notification Details

Device IDK890768
510k NumberK890768
Device Name:PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT
ClassificationPneumocystis Carinii
Applicant GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle,  WA  98121
ContactS Krieger,phd
CorrespondentS Krieger,phd
GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle,  WA  98121
Product CodeLYF  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-15
Decision Date1989-03-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847865001519 K890768 000
00847865001502 K890768 000

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