FIBRINOGEN FDP CONTROL

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

CALA DIAGNOSTICS

The following data is part of a premarket notification filed by Cala Diagnostics with the FDA for Fibrinogen Fdp Control.

Pre-market Notification Details

Device IDK915503
510k NumberK915503
Device Name:FIBRINOGEN FDP CONTROL
ClassificationFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant CALA DIAGNOSTICS P.O. BOX 6714 Los Osos,  CA  93412
ContactJames F Godfrey
CorrespondentJames F Godfrey
CALA DIAGNOSTICS P.O. BOX 6714 Los Osos,  CA  93412
Product CodeDAP  
CFR Regulation Number864.7320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-09
Decision Date1992-01-30

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