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510(k) Data Aggregation
K Number
K983655Device Name
AUTOSTAT II ANA SCREEN ELISAManufacturer
Date Cleared
1999-01-28
(101 days)
Product Code
Regulation Number
866.5100Type
TraditionalPanel
ImmunologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Not Found
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for a device called "Autostat™ II ANA Screen ELISA". It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed.
Therefore, I cannot provide the requested information based on the provided text.
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