K Number
K961896
Device Name
MICROLAB 4000, MICROLAB 4200
Manufacturer
Date Cleared
1996-08-16

(92 days)

Product Code
Regulation Number
862.2750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information

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§ 862.2750 Pipetting and diluting system for clinical use.

(a)
Identification. A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.(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 § 862.9.

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