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510(k) Data Aggregation

K Number

Device Name

QC-BEADS

Manufacturer

BIOSCREEN INC.

Date Cleared

2004-10-29

(25 days)

Product Code

NRF

Regulation Number

864.8625

Why did this record match?

Applicant Name (Manufacturer) :

BIOSCREEN INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

QC-Beads TM are intended for use as controls in counting sperm manually using a microscope or automatically using computer assisted semen analysis instruments.

Device Description

Not Found

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