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FDA 510(k)

ZAP HCG TEST, MODEL 8001

K-Number: K033297 · 2004-03-18

ApplicantZbx Corporation
Decision Date2004-03-18
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ZAP HCG TEST, MODEL 8001 is the device name listed in this FDA 510(k) record. The listed applicant is Zbx Corporation. It received FDA 510(k) clearance on 2004-03-18 under 510(k) number K033297. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZAP HCG TEST, MODEL 8001?

ZAP HCG TEST, MODEL 8001 is a medical device that received FDA 510(k) clearance on 2004-03-18. The listed applicant is Zbx Corporation. The 510(k) number is K033297.

When did ZAP HCG TEST, MODEL 8001 receive FDA 510(k) clearance?

ZAP HCG TEST, MODEL 8001 received FDA 510(k) clearance on 2004-03-18, under 510(k) number K033297.

Who is the listed applicant for ZAP HCG TEST, MODEL 8001?

The FDA 510(k) record lists Zbx Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZAP HCG TEST, MODEL 8001?

The FDA product code for ZAP HCG TEST, MODEL 8001 is JHI.

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Related Devices (Code: JHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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