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FDA 510(k)

HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE

K-Number: K041728 · 2004-08-11

ApplicantImmunostics Inc.,
Decision Date2004-08-11
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Inc.,. It received FDA 510(k) clearance on 2004-08-11 under 510(k) number K041728. 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 HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE?

HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE is a medical device that received FDA 510(k) clearance on 2004-08-11. The listed applicant is Immunostics Inc.,. The 510(k) number is K041728.

When did HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE receive FDA 510(k) clearance?

HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE received FDA 510(k) clearance on 2004-08-11, under 510(k) number K041728.

Who is the listed applicant for HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE?

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

What is the FDA product code for HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE?

The FDA product code for HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE is JHI.

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Related Devices (Code: JHI)

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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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