Search Results
Found 1 results
510(k) Data Aggregation
K Number
K992921Manufacturer
Date Cleared
1999-11-12
(74 days)
Product Code
Regulation Number
864.7470Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Evaluate glycated hemoglobin test accuracy In vitro diagnostic use only
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text is a letter from the FDA to a medical device manufacturer, indicating the clearance of a device. It does not contain information about the acceptance criteria, device performance, study design, or any of the specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.
The document is a legal notification of substantial equivalence, not a summary of a clinical or performance study. Therefore, I cannot extract the requested information from this text.
Ask a Question
Ask a specific question about this device
Page 1 of 1