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FDA 510(k)

STATUS HCG SERUM/URINE

K-Number: K020439 · 2002-05-23

ApplicantPrinceton BioMeditech Corp.
Decision Date2002-05-23
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STATUS HCG SERUM/URINE is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 2002-05-23 under 510(k) number K020439. 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 STATUS HCG SERUM/URINE?

STATUS HCG SERUM/URINE is a medical device that received FDA 510(k) clearance on 2002-05-23. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K020439.

When did STATUS HCG SERUM/URINE receive FDA 510(k) clearance?

STATUS HCG SERUM/URINE received FDA 510(k) clearance on 2002-05-23, under 510(k) number K020439.

Who is the listed applicant for STATUS HCG SERUM/URINE?

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

What is the FDA product code for STATUS HCG SERUM/URINE?

The FDA product code for STATUS HCG SERUM/URINE 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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