FDA 510(k)

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

K-Number: K071930 · 2007-12-18

ApplicantBlue Cross Bio-Medical Co., Ltd.

Decision Date2007-12-18

Product CodeLCX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C is the device name listed in this FDA 510(k) record. The listed applicant is Blue Cross Bio-Medical Co., Ltd.. It received FDA 510(k) clearance on 2007-12-18 under 510(k) number K071930. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C is a medical device that received FDA 510(k) clearance on 2007-12-18. The listed applicant is Blue Cross Bio-Medical Co., Ltd.. The 510(k) number is K071930.

When did ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C receive FDA 510(k) clearance?

ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C received FDA 510(k) clearance on 2007-12-18, under 510(k) number K071930.

Who is the listed applicant for ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C?

The FDA 510(k) record lists Blue Cross Bio-Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C?

The FDA product code for ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C is LCX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.