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510(k) K890768

PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT by Genetic Systems Corp. — Product Code LYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1989
Date Received
February 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pneumocystis Carinii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type

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