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K Number
K960298
Device Name
VIVASPIN 4 10,000 MW
Manufacturer
VIVASCIENCE, INC.
Date Cleared
1996-03-19

(57 days)

Product Code
JJH
Regulation Number
862.2310
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 862.2310 Clinical sample concentrator.

(a)
Identification. A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, and other body fluids before the fluids are analyzed.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.