FDA 510(k)

ONE STEP HCG URINE/SERUM TEST

K-Number: K072500 · 2009-04-21

ApplicantGuangzhou Wondfo Biotech Co., Ltd.

Decision Date2009-04-21

Product CodeDHA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ONE STEP HCG URINE/SERUM TEST is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2009-04-21 under 510(k) number K072500. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE STEP HCG URINE/SERUM TEST?

ONE STEP HCG URINE/SERUM TEST is a medical device that received FDA 510(k) clearance on 2009-04-21. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K072500.

When did ONE STEP HCG URINE/SERUM TEST receive FDA 510(k) clearance?

ONE STEP HCG URINE/SERUM TEST received FDA 510(k) clearance on 2009-04-21, under 510(k) number K072500.

Who is the listed applicant for ONE STEP HCG URINE/SERUM TEST?

The FDA 510(k) record lists Guangzhou Wondfo Biotech 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/SERUM TEST?

The FDA product code for ONE STEP HCG URINE/SERUM TEST is DHA.

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Other records listing Guangzhou Wondfo Biotech Co., Ltd. as applicant

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Related Devices (Code: DHA)

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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.