FIBRI-PREST AUTOMATE HA34

System, Fibrinogen Determination

WELLCOME DIAGNOSTICS

The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Fibri-prest Automate Ha34.

Pre-market Notification Details

Device IDK840211
510k NumberK840211
Device Name:FIBRI-PREST AUTOMATE HA34
ClassificationSystem, Fibrinogen Determination
Applicant WELLCOME DIAGNOSTICS 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeKQJ  
CFR Regulation Number864.7340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-19
Decision Date1984-03-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
13607450006749 K840211 000

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