Stabilized Enzyme Solutions

Solution, Stabilized Enzyme

Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Fo

The following data is part of a De Novo classification by Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Fo with the FDA for Stabilized Enzyme Solutions.

Pre-market Notification Details

DeNovo IDDK780962
Device Name:Stabilized Enzyme Solutions
ClassificationSolution, Stabilized Enzyme
Applicant
ContactDevice Classification Under Section 513(f)(2)(de N
Product CodeKSK  
CFR Regulation Number864.9400 [🔎]
DecisionSubstantially Equivalent (SE)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardHematology
Classification AdvisoryHematology
Type510(k) Traditional
Date Received1978-06-12
Decision Date1978-07-27
Reclassification Order:Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

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