DIACROM *PLG

Plasminogen, Antigen, Antiserum, Control

WELLCOME DIAGNOSTICS

The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Diacrom *plg.

Pre-market Notification Details

Device IDK832591
510k NumberK832591
Device Name:DIACROM *PLG
ClassificationPlasminogen, Antigen, Antiserum, Control
Applicant WELLCOME DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDDX  
CFR Regulation Number866.5715 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-02
Decision Date1983-11-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03607450006582 K832591 000

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