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510(k) Data Aggregation

K Number

Device Name

ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C

Manufacturer

BLUE CROSS BIO-MEDICAL CO., LTD.

Date Cleared

2007-12-18

(158 days)

Product Code

LCX

Regulation Number

862.1155

Why did this record match?

Applicant Name (Manufacturer) :

BLUE CROSS BIO-MEDICAL CO., LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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